Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
17,007
Countries
24
Sites
385
Atherosclerotic cardiovascular disease (ASCVD)
Demonstrate the superiority of inclisiran compared to placebo in reducing the risk of 3P-MACE (composite of CV death, non-fatal MI and non-fatal ischemic stroke) in participants with established ASCVD and a LDL-C ≥1.8 mmol/L (70 mg/dL).
Key facts
- Sponsor
- Novartis Pharma AG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 26 Nov 2021 → ongoing
- Decision date (initial)
- 2024-07-02
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Novartis Pharma AG
External identifiers
- EU CT number
- 2024-510735-21-00
- EudraCT number
- 2021-002006-27
- ClinicalTrials.gov
- NCT05030428
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Pharmacogenomic, Efficacy, Safety
Demonstrate the superiority of inclisiran compared to placebo in reducing the risk of 3P-MACE (composite of CV death, non-fatal MI and non-fatal ischemic stroke) in participants with established ASCVD and a LDL-C ≥1.8 mmol/L (70 mg/dL).
Secondary objectives 5
- To demonstrate the superiority of inclisiran compared to placebo in reducing the risk of cardiovascular death
- To demonstrate the superiority of inclisiran compared to placebo in reducing the risk of 4P-MACE (composite of cardiovascular death, non-fatal myocardial infarction, non-fatal ischemic stroke, and urgent coronary revascularization)
- To demonstrate the superiority of inclisiran compared to placebo in reducing the risk of major adverse limb events (MALE)
- To demonstrate the superiority of inclisiran compared to placebo in reducing the risk of all-cause death
- To evaluate the safety and tolerability of inclisiran compared to placebo
Conditions and MedDRA coding
Atherosclerotic cardiovascular disease (ASCVD)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 26.0 | LLT | 10051615 | Atherosclerotic cardiovascular disease | 10047065 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Male or female ≥40 years of age
- Fasting LDL-C ≥1.8 mmol/L (70 mg/dL) at the Screening Visit
- At the Screening Visit, participants must be on a stable (≥4 weeks) and well-tolerated lipid-lowering regimen (including e.g., with or without Ezetimibe) that must include a high-intensity statin therapy with either atorvastatin ≥40 mg QD or rosuvastatin ≥20 mg QD
- Established CV disease, defined as any of the following: - Previous myocardial infarction - Previous ischemic stroke - Symptomatic peripheral arterial disease (PAD), as evidenced by either intermittent claudication with ABI <0.85, prior peripheral arterial revascularization procedure, or amputation due to atherosclerotic disease
Exclusion criteria 4
- New York Heart Association (NYHA) class III or IV heart failure at the Statin Optimization Screening Visit (if applicable), Screening Visit, or at the Baseline Visit (Day1)
- Previous exposure to inclisiran or any other non-mAb PCSK9-targeted therapy, either as an investigational or marketed drug within 2 years prior to the first study visit
- Pregnant or nursing (lactating) women
- Women of child-bearing potential, unless they are using effective methods of contraception during dosing of study treatment
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Time to first occurrence of cardiovascular death, non-fatal myocardial infarction, or non-fatal ischemic stroke (3P-MACE)
Secondary endpoints 6
- Time to cardiovascular death
- Time to first occurrence of cardiovascular death, non-fatal myocardial infarction, non-fatal ischemic stroke, or urgent coronary revascularization (4P-MACE)
- Time to fist occurrence of Major Adverse Limb Events (MALE)
- Time to all-cause death
- Number of participants with SAEs
- Number of participants with AEs leading to study treatment discontinuation
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SUB182427 · Substance
- Active substance
- Inclisiran
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 3900 mg milligram(s)
- Max treatment duration
- 72 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- The clinical dossier contains alternative packaging sites for supplies for clinical trials which are not included in the MA dossier. The drug substance retest period in the MA dossier is 36 months. The drug product shelf life in the MA dossier is 36 months.
Placebo 1
Placebo to KJX839 (Inclisiran sodium) 0 mg/1.5 mL solution for injection in pre-filled syringe
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Auxiliary 8
SUB05600MIG · Substance
- Active substance
- Atorvastatin
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 175200 mg milligram(s)
- Max treatment duration
- 72 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB05600MIG · Substance
- Active substance
- Atorvastatin
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 175200 mg milligram(s)
- Max treatment duration
- 72 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB05600MIG · Substance
- Active substance
- Atorvastatin
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 175200 mg milligram(s)
- Max treatment duration
- 72 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB05600MIG · Substance
- Active substance
- Atorvastatin
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 175200 mg milligram(s)
- Max treatment duration
- 72 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB20634 · Substance
- Active substance
- Rosuvastatin
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 87640 mg milligram(s)
- Max treatment duration
- 72 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB20634 · Substance
- Active substance
- Rosuvastatin
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 87640 mg milligram(s)
- Max treatment duration
- 72 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB20634 · Substance
- Active substance
- Rosuvastatin
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 87640 mg milligram(s)
- Max treatment duration
- 72 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB20634 · Substance
- Active substance
- Rosuvastatin
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 87640 mg milligram(s)
- Max treatment duration
- 72 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Novartis Pharma AG
- Sponsor organisation
- Novartis Pharma AG
- Address
- Lichtstrasse 35
- City
- Basel
- Postcode
- 4056
- Country
- Switzerland
Scientific contact point
- Organisation
- Novartis Pharma AG
- Contact name
- Novartis Pharma Arzneimittel GmbH
Public contact point
- Organisation
- Novartis Pharma AG
- Contact name
- Novartis Pharma Arzneimittel GmbH
Third parties 27
| Organisation | City, country | Duties |
|---|---|---|
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | Data management |
| Greenphire LLC ORG-100041621
|
King Of Prussia, United States | Other |
| Tamro Oyj ORG-100011802
|
Vantaa, Finland | Other |
| IQVIA RDS Spain S.L. ORG-100014508
|
Madrid, Spain | On site monitoring |
| Mag. Andreas Raffeiner GmbH ORG-100043223
|
Walding, Austria | Code 8 |
| Omnitrace Corp. ORG-100045579
|
Palm Beach Gardens, United States | Other |
| Abf Pharmaceutical Services GmbH ORG-100014752
|
Vienna, Austria | Other |
| IQVIA Limited ORG-100008655
|
Reading, United Kingdom | On site monitoring, Other, Interactive response technologies (IRT) |
| Datacubed Health Inc. ORG-100047227
|
King Of Prussia, United States | Other |
| Movianto Slovensko s.r.o. ORG-100020628
|
Senec, Slovakia | Other |
| Creapharm Clinical Supplies ORG-100020131
|
Le Haillan, France | Other |
| Opis S.r.l. ORG-100011127
|
Desio, Italy | Other |
| Mipharm S.p.A. ORG-100000724
|
Milan, Italy | Other |
| Distica hf. ORG-100022309
|
Gardabaer, Iceland | Other |
| Medpace Reference Laboratories LLC ORG-100041727
|
Cincinnati, United States | Laboratory analysis |
| Oribalt Riga SIA ORG-100012153
|
Marupe, Latvia | Other |
| Syneos Health Inc. ORG-100008382
|
Morrisville, United States | On site monitoring |
| PRA Hellas CRO A.E. ORG-100048208
|
Nea Ionia, Greece | On site monitoring |
| Icon Laboratory Services Inc. ORG-100037135
|
Farmingdale, United States | Laboratory analysis |
| Parexel International (IRL) Limited ORG-100022780
|
Dublin 2, Ireland | On site monitoring, Code 12, Code 2, Code 5 |
| Cleveland Clinic Foundation ORG-100028017
|
Cleveland, United States | Other |
| Medical Intertrade d.o.o. ORG-100001426
|
Sveta Nedelja, Croatia | Other |
| Freja Transport & Logistics AS ORG-100018845
|
Frogner, Norway | Other |
| Icon Clinical Research Limited ORG-100008322
|
Dublin 18, Ireland | On site monitoring |
| Syneos Health Clinical Spain S.L. ORG-100009277
|
Madrid, Spain | On site monitoring |
| WCG Clinical Inc. ORG-100040730
|
Washington, United States | Code 10 |
| Rps Research Iberica S.L. ORG-100030199
|
Barcelona, Spain | On site monitoring |
Locations
24 EU/EEA countries · 385 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruitment ended | 8 | 2 |
| Belgium | Ongoing, recruitment ended | 138 | 14 |
| Bulgaria | Ongoing, recruitment ended | 638 | 29 |
| Croatia | Ongoing, recruitment ended | 215 | 17 |
| Czechia | Ongoing, recruitment ended | 584 | 27 |
| Denmark | Ongoing, recruitment ended | 120 | 9 |
| Estonia | Ongoing, recruitment ended | 67 | 8 |
| Finland | Ongoing, recruitment ended | 53 | 5 |
| France | Ongoing, recruitment ended | 296 | 32 |
| Greece | Ongoing, recruitment ended | 53 | 7 |
| Hungary | Ongoing, recruitment ended | 427 | 20 |
| Iceland | Ongoing, recruitment ended | 54 | 2 |
| Italy | Ongoing, recruitment ended | 142 | 17 |
| Latvia | Ongoing, recruitment ended | 83 | 8 |
| Lithuania | Ongoing, recruitment ended | 360 | 11 |
| Netherlands | Ongoing, recruitment ended | 646 | 22 |
| Norway | Ongoing, recruitment ended | 80 | 8 |
| Poland | Ongoing, recruitment ended | 874 | 26 |
| Portugal | Ongoing, recruitment ended | 231 | 12 |
| Romania | Ongoing, recruitment ended | 350 | 19 |
| Slovakia | Ongoing, recruitment ended | 494 | 26 |
| Slovenia | Ongoing, recruitment ended | 31 | 5 |
| Spain | Ongoing, recruitment ended | 684 | 50 |
| Sweden | Ongoing, recruitment ended | 145 | 9 |
| Rest of world
Philippines, Israel, Colombia, South Africa, Mauritius, Japan, India, Argentina, Chile, Malaysia, China, Turkey, Thailand, Brazil, Australia, Mexico, Serbia, United States, Taiwan, Kenya, Singapore, Canada, New Zealand, Korea, Republic of, Russian Federation
|
— | 10,234 | — |
Investigational sites
Medical University Of Graz
Clin. Dep. Cardiology, Neue Stiftingtalstrasse 6, 8010, Graz
A.O. Krankenhaus St. Josef Braunau GmbH
Innere Medizin I, Ringstrasse 60, 5280, Braunau Am Inn
Az St-Jan Brugge-Oostende A.V.
7113: Laboratory, Ruddershove 10, 8000, Brugge
Association Hospitaliere De Bruxelles Et De Schaerbeek Centre Hospitalier Universitaire Brugmann
7107: Cardiologie, Arthur Van Gehuchtenplein 4, 1020, Brussels
Ziekenhuis Oost Limburg
7112: Algemene Cardiologie, Synaps Park 1, 3600, Genk
Algemeen Ziekenhuis Groeninge
7109: Cardiologie, President Kennedylaan 4, 8500, Kortrijk
AZ Sint-Lucas & Volkskliniek
7110: AZ Sint-Lucas - Campus Sint-Lu, Groenebriel 1, 9000, Gent
Algemeen Ziekenhuis Klina
7103: Cardiologie, Augustijnslei 100, 2930, Brasschaat
Antwerp University Hospital
7111: Cardiologie, Drie Eikenstraat 655, 2650, Edegem
Centre hospitalier universitaire de Tivoli Institut medical des Mutualites socialistes
7106: rhumatologie, Avenue Max Buset 34, 7100, La Louviere
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
7101: Cardiology, Avenue Docteur Gaston Therasse 1, 5530, Yvoir
Algemeen Ziekenhuis Delta
7116: Hartziekten, Deltalaan 1, 8800, Roeselare
Grand Hopital De Charleroi
7115: Médecine Interne Génerale et infectiologie, Rue Marguerite Depasse 6, 6060, Charleroi
Az Maria Middelares Gent
7105: Cardiologie, Buitenring-Sint-Denijs 30, 9000, Gent
Werken Glorieux
7104: Cardiologie, Stefaan Modest Glorieuxlaan 55, 9600, Ronse
Het Ziekenhuisnetwerk Antwerpen
7102: Hartziekten (Cardiologie), Lindendreef 1, 2020, Antwerp
Ambulatory of specialized outpatient medical help in internal diseases and cardiology Individual practice Cardio Tonus EOOD
7301: NA, Druzhba II Bl 284 Ent А Fl 0 Ap М14 5, District Iskar, Sofia
Medical Center Teodora EOOD
7319: NA, Ulitsa Mutkurova 101, 7000, Ruse
Medical Center Medconsult Pleven OOD
7304: NA, Floor 4, Ulitsa Sveti Sveti Kiril I Metodiy 18, Pleven
Uniteversity Muliprofile Hospital For Active Treatment Tsaritsa Yoanna-Isul EAD
7321: Cardiology Clinic, Oborishte Distr., Ul.Byalo More 8, Sofia
Ambulatory For Individual Practice For Specialized Medical Care Kokon Krasimirova EOOD
7325: NA, Cabinet 1 Floor 1, Ulitsa Krivolak 7, Sliven
Medical Center Excelsior OOD
7303: NA, Lozenets, Ulitsa Golo Birdo 4, Sofiya
Ambulatory For Individual Practice For Primary Medical Aid AIPPMP Dr. Zhaneta Demireva EOOD
7327: NA, 2 Antim I Street 2nd Floor Cabinets 1 2 3 And 4, 4210, Stamboliyski
Multiprofile Regional Hospital For Active Treatment Dr. Stefan Cherkezov AD
7314: Cardiology Department, Ulitsa Nish 1, 5002, Veliko Tirnovo
Medical Center Prolet EOOD
7310: NA, Ulitsa Olimpi Panov 25, 7000, Ruse
Medical Center Hera - Kyustendil EOOD
7311: NA, Ulitsa Morits Levi 2, 2500, Kyustendil
Мultidisciplinary hospital for active treatment Saint George Pernik OOD
7309: Department of Cardiology, Ulitsa Sveti Kiril I Metodiy 77, 2300, Pernik
Diagnostics And Consultation Center Convex Ltd.
7320: NA, Ulitsa Sinanishko Ezero 11a, 1680, Sofiya
Medical Center Doktor Staykov Ltd.
7324: NA, Ulitsa Transportna 33, 8008, Burgas
Diagnostic Consultative Centre Ascendent EOOD
7515: NA, Ulitsa Bacho Kiro 47, 1202, Sofia
Medical Center Hera EOOD
7306: NA, Ulitsa Klisura 20, 1510, Sofiya
South West Hospital Ltd.
7616: Cardiology Department, Park Area, 2800, Sandanski
Multidisciplinary Hospital For Active Treatment Haskovo AD
7318: Cardiology Department, Bulevard Siedinenie 49, 6304, Haskovo
Medicinski Centar Hipokrat-N EOOD
7329: NA, Ulitsa Dragota 6, 4003, Plovdiv
ASIMPKIP D-R Elena Docheva EOOD
7328: NA, Zornitsa 58 Bl Fl1 Room 14, 8000, Burgas
Medical Center Excelsior OOD
7326: NA, Lozenets, Ulitsa Golo Birdo 4, Sofiya
Multi-profile Hospital for Active Treatment Heart and Brain EAD
7312: Department of Cardiology, Pierre Curie Street 2, 5804, Pleven
Diagnostic Consultative Center II Sofia EOOD
7517: NA, Ulitsa Han Krum 1, 1000, Sofia
Umbal - Prof. D-R Stoyan Kirkovich AD
7308: Cardiology clinic, Ulitsa General Stoletov 2, 6003, Stara Zagora
University Multidisciplinary Hospital for Active Treatment Sveta Ekaterina EAD
7307: Cardiology clinic, Bulevard Pencho Slaveykov 52a, 1431, Sofia
University Hospital St. Anna
7323: Clinic of Internal Diseases, Ulitsa Dimitir Mollov 1, 1750, Sofia
Medical Center Hera EOOD
7305: NA, Ulitsa Tsar Boris Treti 11a, Fl 2, Montana
Diagnostic-Consultative Center 22 Sofia EOOD
7313: NA, Ulitsa Nikolay Kopernik 9, 1113, Sofiya
Medical Center Dea Medicals EOOD
7302: NA, Ulitsa Hristo Botev 51, 2500, Kyustendil
Orpheus Medical Center OOD
7322: NA, Orpheus Street 4, 6000, Stara Zagora
University Hospital Sveti Duh
2107: Cardiology, Sveti Duh 64, 10000, Zagreb
Thalassotherapia Specijalna bolnica za medicinsku rehabilitaciju bolesti srca pluca i reumatizma
2106: Cardiology, Marsala Tita 188/1, 51410, Opatija
Clinical Hospital Dubrava
2118: Cardiology, Avenija Gojka Suska 6, Zagreb, Grad Zagreb
Klinicki Bolnicki Centar Osijek
2109: Cardiology, Ulica Josipa Huttlera 4, 31000, Osijek
KBC Zagreb
2105: Internal medicine, Ulica Mije Kispatica 12, Zagreb, Grad Zagreb
AGRAM Special Hospital
2117: Cardiology, Trnjanska Cesta 108, Zagreb, Grad Zagreb
Clinical Hospital Centre Rijeka
2103: Cardiology, Kresimirova 42, 51000, Rijeka
Klinicki bolnicki centar Sestre milosrdnice
2111: Cardiology, Vinogradska Cesta 29, Zagreb, Grad Zagreb
Polyclinic Victus
2116: Cardiology, Kneza Mislava 15, 10000, Zagreb
General Hospital Dr. Josip Bencevic
2144: Cardiology, Ulica Dr. Andrije Stampara 42, 35000, Slavonski Brod
KBC Zagreb
2100: Cardiology, Ulica Mije Kispatica 12, Zagreb, Grad Zagreb
General Hospital Dr. Josip Bencevic
2115: Cardiology, Ulica Dr. Andrije Stampara 42, 35000, Slavonski Brod
KBC Split
2113: Cardiology, Spinciceva 1, 21000, Split
Clinical Hospital Centre Rijeka
2112: Cardiology, Kresimirova 42, 51000, Rijeka
Zupanijska Bolnica Cakovec
2102: Cardiology, I. G. Kovacica 1e, 40000, Cakovec
Klinicki Bolnicki Centar Osijek
2108: Cardiology, Ulica Josipa Huttlera 4, 31000, Osijek
Specijalna Bolnica Za Medicinsku Rehabilitaciju Krapinske Toplice
2104: Cardiology, Ulica Ljudevita Gaja 2, 49217, Krapinske Toplice
Clinical Trials Service s.r.o.
7514, Masarykovo Namesti 155, 686 01, Uherske Hradiste
InterKardioML s.r.o.
7522, Krizikova 715/9, 353 01, Marianske Lazne
Pedicor Care s.r.o.
7524, Horni 266/73, Dubina, Ostrava
Fakultni Nemocnice Hradec Kralove
7511: I.interni kardioangiologicka klinika, Sokolska 581, 500 03, Novy Hradec Kralove
Nemocnice Jihlava prispevkova organizace
7510: Kardiologicke oddeleni, Vrchlickeho 4630/59, 586 01, Jihlava 1
Policska nemocnice s.r.o.
7505: Interni ambulance, Eimova 294 Horni Predsmesti, 572 01, Policka
Cardio Research s.r.o.
7501: Kardiologicka ambulance, J. A. Bati 5645, 760 01, Zlin
Fakultni Nemocnice Brno
7517: I. Interni kardiologicka klinika, Jihlavska 340/20, Bohunice, Brno
Kardio Elbl s.r.o.
7516: Kardiologicka ambulance, Halasovo Namesti 597/1, Lesna, Brno-Sever
Kardiologie Vinohrady s.r.o.
7507, Vodickova 1935/38, Nove Mesto, Prague 1
Nemocnice Pardubickeho kraje a.s.
7503: Interni oddeleni, Kollarova 643/7, Predmesti, Svitavy
Dr.Kuchar Kardiologie s.r.o
7523, Trida Miru 187, 381 01, Latran
MaderMED s.r.o.
7518, Chittussiho 1001/9, 710 00, Slezska Ostrava
Corintez s.r.o.
7527: Interni a kardiologicka ordinace, Seydlerova 2451/8, Stodulky, Prague 13
Kardio s.r.o.
7502, Vltavinskla 1289, 674 01, Trebic
Nemocnice Slany
7508: Interni oddeleni, Politickych Veznu 576, 274 01, Slany
Centrum klinickeho vyzkumu s.r.o.
7526, Cechovska 57, 261 01, Pribram VIII
Edumed s.r.o.
7519, Smetanova 91, 550 01, Broumov
Fakultni Nemocnice U Sv Anny V Brne
7520: I. interni kardioangiologicka klinika, Pekarska 53, Stare Brno, Brno-Stred
KardioBusak s.r.o.
7504, Kosmonautu 2303, 440 01, Louny
CTC Hodonin s.r.o.
7530: Cevni ambulance, Kollarova 4338/9, 695 01, Hodonin
Fakultni Nemocnice Kralovske Vinohrady
7515: Kardiologicka klinika, Srobarova 1150/50, Vinohrady, Prague
Mrozek Kardiologie s.r.o.
7512, Na Porici 1190, 738 01, Frydek
Nemocnice Pardubickeho kraje a.s.
7525: Kardiologicke oddeleni, Kyjevska 44 Pardubicky, 530 03, Pardubice
ROcardia s.r.o.
7529, Lomena 4572/4, 796 04, Prostejov
AGEL Stredomoravska nemocnicni a.s.
7509: Interni oddeleni, Dvorakova 75, 751 52, Prerov
MUDr. Libor Nechvatal s.r.o.
7521, Hybesova 289/43, Stare Brno, Brno-Stred
Region Sjaelland
7607:Department of Cardiology Research, Sygehusvej 10, 4000, Roskilde
Odense University Hospital
7603:Cardiovascular Research Unit, Department of Medicine, Baagoees Alle 15, 5700, Svendborg
Region Midtjylland
7604:Department of Cardiology, G313, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N
Esbjerg Og Grindsted Sygehus
7608:Department of Cardiology Research, Finsensgade 35, 6700, Esbjerg
Regionshospital Nordjylland
7609:Department of Cardiology, Bispensgade 37, 9800, Hjoerring
Region Midtjylland
7605:Hjerteklinikken (Cardiology outpatient clinic), Heibergs Alle 5a, 8800, Viborg
Region Midtjylland
7601:Cardiovascular Research Unit, Hospitalsparken 15, 7400, Herning
Gentofte Hospital
7606:Hjertemedicinsk Forskning 1, Niels Andersens Vej 65, 2900, Hellerup
Rigshospitalet
7602:Klinisk Forskningsenhed 9631, Blegdamsvej 9, 2100, Copenhagen Oe
Liina Viitas OÜ
2212: Private Clinic (endocrinology), Veetorni 2-1, 80018, Paernu
Innomedica OÜ
2203: Private clinic, Narva Mnt 7, Kesklinna Linnaosa, Tallinn
East Tallinn Central Hospital
2201: Internal clinic, heart clinic (Südamekeskus), Ravi Tn 18, Kesklinna Linnaosa, Tallinn
North Estonia Medical Centre Foundation
2200: Department of Cardiac Intensive Care, J. Sutiste Tee 19, Mustamae Linnaosa, Tallinn
Aktsiaselts Medicum Tervishoiuteenused
2207: Internal medicine department, Punane Tn 61, Lasnamae Linnaosa, Tallinn
Dr Arvo Rosenthal OÜ
2202: Private clinic (cardiology), J Sutiste Tee 19a-198 Korpus, 13419, Tallinn
Tartu University Hospital
2208: Second Cardiology Department, A006, L. Puusepa Tn 8, Tartu Linn
MediTrials OÜ
2206: Private Clinic, Moisavahe Tn 34c, 50708, Tartu Linn
Health Step Finland Oy
4501: Internal Medicine, Medistudia 5th Floor, Yliopistonrinne 3, Kuopio
StudyCor Oy
4502: Heart Hospital, Hoitajantie 4, 40620, Jyvaskyla
Turku University Hospital
4503: Heart Centre, Hameentie 11, 20520, Turku
Geri-Med Oy
4500:Department of Medicine, Leppasuonkatu 9 C, 00100, Helsinki
Suomen Terveystalo Oy
4504: Internal Medicine, Humalistonkatu 9 11, 20100, Turku
Centre Hospitalier De Beziers
2340: Service de Cardiologie, Zone Dactivite Montimaran, 2 Rue Valentin Hauy, Beziers
Centre Hospitalier Regional Et Universitaire De Brest
2320: Service de Cardiologie, Boulevard Tanguy Prigent, 29200, Brest
Centre Hospitalier De Cholet
2343: Service de Médecine Vasculaire, 1 Rue De Marengo, 49300, Cholet
Centre Hospitalier Universitaire De Rennes
2321: Cardiologie, 2 Rue Henri Le Guilloux, 35000, Rennes
Centre Hospitalier Sud Francilien
2308:Service de Cardiologie, 40 Avenue Serge Dassault, 91100, Corbeil Essonnes
Assistance Publique Hopitaux De Paris
2307: Service de Cardiologie, 46 Rue Henri Huchard, 75877, Paris Cedex 18
Centre Hospitalier De Tourcoing
2302: Service de Cardiologie, 155 Rue Du President Coty, Bp 40619, Tourcoing Cedex
Centre Hospitalier Universitaire De Nimes
2312: Service de Cardiologie, Place Du Professeur Robert Debre, 30900, Nimes
Hopital Prive De Villeneuve D'Ascq
2314: Cardiologie, Quartier Du Recueil, 20 Rue De La Reconnaissance, Villeneuve D Ascq
CHU Gabriel-Montpied
2335:Service de Cardiologie, 58 Rue Montalembert, 63000, Clermont Ferrand
Centre Hospitalier Universitaire Reims
2326: Service Cardiologie, Rue Du General Koenig, 51092, Reims Cedex
Centre Hospitalier Universitaire De Montpellier
2300: Service de Cardiologie, 371 Avenue Du Doyen Gaston Giraud, 34090, Montpellier
Assistance Publique Hopitaux De Paris
2317: Département de Cardiologie, 2 Rue Ambroise Pare, 75010, Paris
Centre Hospitalier Universitaire De Lille
2327: Service USIC et Centre Hémodynamique, Boulevard Du Professeur Jules Leclercq, 59000, Lille
Centre Hospitalier Saint Joseph Saint Luc
2315: Cardiologie Interventionnelle, 20 Quai Claude Bernard, 69007, Lyon
Centre Hospitalier De Pau
2323 :Service de Cardiologie, 4 Boulevard Hauterive, 64000, Pau
Clinique Du Pont De Chaume
2306: Service de Cardiologie, 330 Avenue Marcel Unal, 82000, Montauban
Centre Hospitalier Universitaire De Poitiers
2336: Service de Cardiologie, 2 Rue De La Miletrie, 86000, Poitiers
Centre Hospital Region Metz Thionville
2339:Service de Cardiologie, 1 Allee Du Chateau, Cs 45001 Ars Laquenexy, Metz Cedex 03
University Hospitals Pitie Salpetriere Charles Foix
2334: Institut de Cardiologie, 47 To 83 Boulevard De L Hopital, 75013, Paris
Polyclinique Vauban
2304: Service Cardiologie, 10 Avenue Vauban, 59300, Valenciennes
Centre Hospitalier Regional Universitaire De Tours
2301: Service de Cardiologie, Avenue De La Republique, 37170, Chambray Les Tours
Centre Hospitalier Universitaire De Toulouse
2313 : Département de Cardiologie, 1 Avenue Du Professeur Jean Poulhes, Tsa 50032, Toulouse Cedex 9
Centre Hospitalier Universitaire Grenoble Alpes
2316: Service de Cardiologie, Boulevard De La Chantourne, Cs 10217, Grenoble Cedex 9
Les Hopitaux De Chartres
2303:Service de Cardiologie, 4 Rue Claude Bernard, 28630, Le Coudray
Centre Hospitalier Universitaire De Bordeaux
2337: Cardiologie, Avenue De Magellan, 33600, Pessac
Centre Hospitalier Universitaire De Nice
2318 : Service de Cardiologie, 30 Voie Romaine, 06000, Nice
Assistance Publique Hopitaux De Paris
2309: Service de Cardiologie, 20 Rue Leblanc, 75015, Paris
Centre Hospitalier Universitaire D Orleans
2328: Service de Cardiologie, 14 Avenue De L Hopital, Cs 86709, Orleans Cedex 2
Centre Hospitalier Universitaire Amiens Picardie
2342 :Service de Médecine Vasculaire, 1 Rond Point Du Pr Christian Cabrol, 80054, Amiens Cedex 1
Centre Hospitalier Regional De Marseille
2345: Unité Neurovasculaire, 264 Rue Saint Pierre, 13005, Marseille
Centre Hospitalier Et Universitaire De Limoges
2310:Département de Cardiologie, 2 Avenue Martin Luther King, 87000, Limoges
University General Hospital Of Ioannina
4701: 1st Internal Medicine Clinic, Niarchou Stavrou Avenue, 455 00, Ioannina
Laiko General Hospital Of Athens
4703 : 1st Propedeutic Internal Medicine Clinic, Agiou Thoma (goudi) 17, 115 27, Athens
General University Hospital Of Larissa
4710:Internal Medicine Clinic, P. O. Box 1425, 411 10, Larissa
Hippokration Hospital
4706:1st Cardiology Department, Vassilissas Sofias Avenue 114, 115 27, Athens
Athens Naval Hospital
4702: Cardiology Clinic, Dinokratous 70, 115 21, Athens
Alexandra Hospital
4707: Department of Clinical Therapeutics, Vassilissas Sofias Avenue 80, 115 28, Athens
Athens Medical Center S.A.
4711: Department of Internal Medicine, Pylea, Asklipiou 10, Thessaloniki
Bacs-Kiskun Varmegyei Oktatokorhaz
7811: I. Belgyógyászat-Kardiológia Osztály, Nyiri Ut 38, 6000, Kecskemet
Coromed-Smo Kft.
7802: NAP, Jaszai Mari Utca 3, 7623, Pecs
University Of Pecs
7814: I. Belgyógyászati Klinika, Ifjusag Utja 13, 7624, Pecs
Tolna Varmegyei Balassa Janos Korhaz
7805: Belgyógyászati Osztály, Beri Balogh Adam Utca 5-7, 7100, Szekszard
Central Hospital Of Northern Pest Military Hospital
7816: Kardiológiai Osztály, Robert Karoly Korut 44, 1134, Budapest XIII
Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet
7812: Kardiológiai Osztály, Toszegi Ut 21, 5000, Szolnok
Kalo Sbo Kft.
7821: NAP, Kossuth Lajos Utca 34-36, 6300, Kalocsa
University Of Debrecen
7804: Belgyógyászati Klinika, Nagyerdei Korut 98, 4032, Debrecen
Semmelweis University
7801: III. sz. Belgyógyászati Klinika, Szentkiralyi Utca 46, VIII Kerulet, Budapest VIII
Bajai Szent Rokus Korhaz
7819: Neurológia, Rokus Utca 10, 6500, Baja
Budapesti Uzsoki Utcai Korhaz
7807: Kardiológia, Uzsoki Utca 29-41, 1145, Budapest XIV
Albert Schweitzer Korhaz Rendelointezet
7822: Ideggyógyászat, Balassi Balint Ut 16, 3000, Hatvan
Belvarosi Egeszseghaz Kft.
7808: NAP, Platan Sor 2-4, 8900, Zalaegerszeg
Dr. Laszlo Elek Korhaz Es Rendelointezet Oroshaza
7815: Kardiológia, Kond Utca 59, 5900, Oroshaza
University Of Szeged
7813: Családorvosi Intézet és Rendelő, Tisza Lajos Korut 109, 6725, Szeged
DRC Kft.
7809: NAP, Ady Endre Utca 12/b, 8230, Balatonfured
Kistarcsai Flor Ferenc Korhaz
7806: V. Belgyógyászat, Semmelweis Ter 1, 2143, Kistarcsa
Semmelweis University
7818: Városmajori Szív- és Érgyógyászati Klinika, Varosmajor Utca 68, Kerulet, Budapest XII
Komaromi Selye Janos Korhaz
7820: Kardiológia I, Szechenyi Utca 2, Szony, Komarom
Kanizsai Dorottya Korhaz
7817: Kardiológia Osztály és Koronária Őrző, Szekeres Jozsef Utca 2-8, 8800, Nagykanizsa
Hjartamidstoedin ehf.
4601:Hjartamidstodin, Holtasmari 1, 201, Kopavogur
Landspitali
4602:Dept.Cardiology,10D, Hringbraut 101, 101, Reykjavik
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
2504: U.O.C. di Cardiologia, Piazzale Spedali Civili 1, 25123, Brescia
Azienda USL Toscana Sud Est
2506: U.O.C. di Cardiologia, Via Senese 169, 58100, Grosseto
Azienda Ospedaliera Universitaria Senese
2505 : U.O.C. di Cardiologia, Viale Mario Bracci 1, 53100, Siena
Istituto Neurologico Mediterraneo Neuromed S.p.A.
2501: U.O.C. di Angio-Cardio-Neurologia e Medicina Traslazionale, Via Atinense N. 18, 86077, Pozzilli
Azienda Ospedaliero Universitaria Di Modena
2511: U.O.C. Medicina ad Indirizzo Metabolico, Via Pietro Giardini 1355, 41126, Modena
Careggi University Hospital
2508: S.O.D. Malattie Aterotrombotiche, Largo Giovanni Alessandro Brambilla 3, 50134, Florence
ASST Grande Ospedale Metropolitano Niguarda
2502: S.C. Cardiologia 4, Piazza Dell'ospedale Maggiore 3, 20162, Milan
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
2520: S.C. Cardiologia U, Corso Bramante 88, 10126, Turin
Azienda Ospedaliero Universitaria Di Sassari
2521:U.O.C. Cardiologia Clinica e Interventistica, Viale San Pietro 10, 07100, Sassari
Humanitas Mirasole S.p.A.
2519: U.O. di Cardiologia, Via Alessandro Manzoni 56, 20089, Rozzano
Azienda Unita Sanitaria Locale Di Bologna
2517: U.O.C. Cardiologia, Largo Bartolo Nigrisoli 2, 40133, Bologna
Centro Cardiologico Monzino S.p.A.
2509: U.O. Cardiologia Critica e Riabilitativa, Via Carlo Parea 4, 20138, Milan
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
2513: U.O. di Medicina Interna, Via Pietro Albertoni 15, 40138, Bologna
Santa Maria Degli Angeli Hospital
2515: U.O.C. Cardiologia, Via Montereale 24, 33170, Pordenone
University Hospital Of Ferrara
2514: U.O. di Cardiologia ed UTIC Centro Scompenso, Cona, Via Aldo Moro 8, Ferrara
ASST Grande Ospedale Metropolitano Niguarda
2503 : Centro Dislipidemie, Piazza Dell'ospedale Maggiore 3, 20162, Milan
Ospedale San Raffaele S.r.l.
2512: Unità Cardio Metabolica e Trials Clinici, Via Olgettina 60, 20132, Milan
Rigas 1. slimnica SIA
8003, Bruninieku Iela 5, LV-1001, Riga
Daugavpils Regional Hospital SIA
8002, Vasarnicu Iela 20, 5417, Daugavpils
Rutas Eglites Gimenes Arsta Prakse SIA
8006, Smilsu Iela 22, LV-3301, Kuldiga
Vidzemes Slimnica SIA
8004, Jumaras Iela 195, 4201, Valmiera
Pauls Stradins Clinical University Hospital
8005, Pilsonu Iela 13, 1002, Riga
Liepajas Regionala Slimnica SIA
8007, Slimnicas Iela 25, 3414, Liepaja
Adoria SIA
8001, Aleksandra Caka Street 70-3, 1011, Riga
Rigas Austrumu kliniska universitates slimnica SIA
8008, Hipokrata Iela 2, 1038, Riga
Vilniaus Universiteto Ligonine Santaros Klinikos Vsi
8103, Santariskiu G 2, Vilniaus M. Sav., Vilnius
Klaipedos universiteto ligonine VšĮ
8101, Liepojos G. 45, Klaipedos M. Sav., Klaipeda
Pirmoji Viltis UAB
8105, P. Luksio G. 8, Siauliu M. Sav., Siauliai
Inmedica UAB
8104, Savanoriu Pr. 169, Kauno M. Sav., Kaunas
Saules seimos medicinos centras UAB
8102, Partizanu G. 27d, Kauno M. Sav., Kaunas
Viesoji istaiga Siauliu centro poliklinika
8110, Vytauto G. 101, Siauliu M. Sav., Siauliai
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos
8107, Eiveniu G. 2, Kauno M. Sav., Kaunas
Panevezys Republican Hospital VšĮ
8108, Smelynes G. 25, Panevezio M. Sav., Panevezys
Inmedica UAB
8111, Petro Baublio G. 2, Vilniaus M. Sav., Vilnius
Klinikiniai Sprendimai UAB
8109, Vilties G. 4-46, Alytaus M. Sav., Alytus
Klinikiniai Sprendimai UAB
8106, P. Luksio G. 3, Kauno M. Sav., Kovno
Ziekenhuis Amstelland
2613:Cardiology, Laan Van De Helende Meesters 8, 1186 AM, Amstelveen
Leids Universitair Medisch Centrum (LUMC)
2617:Cardiology, Albinusdreef 2, 2333 ZA, Leiden
Ziekenhuis Rivierenland
2610:Cardiology, President Kennedylaan 1, 4002 WP, Tiel
Slingeland Ziekenhuis
2611:Cardiology, Kruisbergseweg 25, 7009 BL, Doetinchem
Medisch Centrum Leeuwarden B.V.
2609:Hart- en vaatcentrum, Henri Dunantweg 2, 8934 AD, Leeuwarden
D & A Research B.V.
2602:Cardiology, Hegedyk 9, 8601 ZR, Sneek
Deventer Ziekenhuis
2603:Cardiology, Nico Bolkesteinlaan 75, 7416 SE, Deventer
Amphia Hospital
2601:Cardiology, Molengracht 21, 4818 CK, Breda
Stichting Martini Ziekenhuis
2607:Cardiology, Van Swietenplein 1, 9728 NT, Groningen
Spaarne Gasthuis Stichting
2612:Cardiology, Boerhaavelaan 22, 2035 RC, Haarlem
Stichting Viecuri Medisch Centrum voor Noord-Limburg
2621:Cardiology, Tegelseweg 210, 5912 BL, Venlo
Universitair Medisch Centrum Groningen
2614:Cardiology, Hanzeplein 1, 9713 GZ, Groningen
Alrijne Zorggroep Stichting
2600:Cardiology, Simon Smitweg 1, 2353 GA, Leiderdorp
Meander Medisch Centrum
2608:Cardiology, Maatweg 3, 3813 TZ, Amersfoort
Noordwest Ziekenhuisgroep Stichting
2618:Nephrology and internal medicine, Wilhelminalaan 12, 1815 JD, Alkmaar
Stichting OLVG
2619:Cardiology, Oosterpark 9, 1091 AC, Amsterdam
Groene Hart Ziekenhuis
2605:Cardiology, Bleulandweg 10, 2803 HH, Gouda
Amsterdam UMC Stichting
2615:Vascular Medicine, Meibergdreef 9, 1105 AZ, Amsterdam
Isala Klinieken Stichting
2606:Cardiology, Reggersweg 2, 7943 KC, Meppel
Canisius Wilhelmina Ziekenhuis
2616:Internal Medicine, Weg Door Jonkerbos 100, 6532 SZ, Nijmegen
Elisabeth-Tweesteden Ziekenhuis
2604:Cardiology, Dr. Deelenlaan 5, 5042 AD, Tilburg
Stichting Radboud universitair medisch centrum
2620:Cardiology, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen
Akershus University Hospital
4403: Hjertemedisinsk avdeling, Sykehusveien 25, 1474, Loerenskog
Sorlandet Sykehus HF
4406: Hjertemedisinsk avdeling, Sykehusveien 1, 4838, Arendal
Oslo University Hospital HF
4401: Lipidklinikken, Trondheimsveien 235, 0586, Oslo
Skedsmo Medisinske Senter AS
4405, Presthagaveien 20, 2020, Skedsmokorset
Universitetssykehuset Nord-Norge HF
4408: Hjertemedisinsk avdeling, Sykehusvegen 38, 9019, Tromsoe
Stavanger HF, Stavanger universitetssykehus
4404: Stavanger Helseforskning, Jan Johnsensgt 5, 4011, Stavanger
Drammen Sykehus
4407: Forsknings avdelingen, Dronninggata 28, 3004, Drammen
Oslo University Hospital HF
4400, Taarnbygget, Kirkeveien 166, Oslo
Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M.Kopernika W Lodzi
8505:Oddzial Kardiologiczny, Ul. Pabianicka 62, 93-513, Lodz
Futuremeds Sp. z o.o.
8527:Futuremeds Olsztyn, Ul Waclawa Osinskiego 9, 10-010, Olsztyn
Ko-Med Nova Sp. z o.o.
8510:KO-MED Nova Zamosc, Ul. Peowiakow 1, 22-400, Zamosc
Specjalistyczna Praktyka Lekarska Ewa Mirek-Bryniarska
8509: Cardiology, ul. Kazimierza Wielkiego 118, 30-082, Krakow
Medicor Plus Kardiolodzy Sp. z o.o.
8512:Cardiology, Ul. Warszawska 2/4 Lok. 6, 87-800, Wloclawek
Krakowskie Centrum Medyczne Sp. z o.o.
8525:Cardiology, Ul. Mikolaja Kopernika 32 St, 31-501, Cracow
Prywatny Gabinet Lekarski Jacek Gessek
8504: Cardiology, ul. Szosa Chelminska 38, 87-100, Torun
Kardio.Clinic T. Osadnik P. Wieczorek P. Zurek Sp. j.
8523:kardio.CLINIC Poradnie Specjalistyczne, Ul. Kardynala Stefana Wyszynskiego 1, 41-300, Dabrowa Gornicza
Clinmedica Research Sp. z o.o.
8534:Cardiology, Ul. Ogrodowa 21/23, 96-100, Skierniewice
Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Pulawach
8514:Szpital Specjalistyczny, Oddzial Kardiologii, Ul. Jozefa Bema 1, 24-100, Pulawy
Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k.
8530:Centrum Medyczne Plejady, U2 U3 U4 U5, Ul. Tadeusza Szafrana 5d, Cracow
NZOZ PRO CORDIS Sopockie Centrum Badan Kardiologicznych
8517: Cardiology, ul. Partyzantow 39/64, 81-423, Gdynia
Specjalistyczna Poradnia Kardiologiczna i Nadcisnienia Tetniczego
8516: Cardiology, ul. Okrzei 22, 25-525, Kielce
Zespol Opieki Zdrowotnej W Klodzku
8513:Oddzial Kardiologiczny, Ul. Szpitalna 1a, 57-300, Klodzko
Aka-Med Centrum Sp. z o.o. S.K.
8533:Cardiology, Ul. 1 Maja 323, 41-710, Ruda Slaska
Szpital Grochowski Im.Dr Med. Rafała Masztaka Sp. z o.o.
8520:Oddzial Kardiologii, Ul. Grenadierow 51/59, 04-073, Warsaw
Kresmed Sp. z o. o.
8508:Trial Medica, Ul. Waska 15a, 15-481, Bialystok
Uniwersyteckie Centrum Kliniczne
8528:I Klinika Kardiologii, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
Ostrowieckie Centrum Medyczne Anna Olech Cudzik Krzysztof Cudzik s.c.
8502:Cardiology, Ul. Ilzecka 31a, 27-400, Ostrowiec Swietokrzyski
Michal Tomaszewski Indywidualna Praktyka Lekarska
8532: Cardiology, ul. Leszczynskiego 25 lok.U0.09, 20-068, Lublin
Futuremeds Sp. z o.o.
8526:Cardiology, Ul. Legnicka 16, 53-673, Wroclaw
Podhalanski Szpital Specjalistyczny Im. Jana Pawla II W Nowym Targu
8507:Oddzial Kardiologii, Ul. Szpitalna 14, 34-400, Nowy Targ
Mazowiecki Szpital Specjalistyczny Im.Dr.Jozefa Psarskiego W Ostrolece
8518:Oddzial Kardiologiczny, Aleja Jana Pawla II 120a, 07-410, Ostroleka
Uniwersytecki Szpital Kliniczny W Bialymstoku
8522:Klinika Kardiologii z Oddzialem Intensywnego Nadzoru Kardiologicznego, Ul. Marii Curie-Sklodowskiej 24a, 15-276, Bialystok
Medicover Integrated Clinical Services Sp. z o.o.
8503:MICS Centrum Medyczne Bydgoszcz, Ul. Jana Karola Chodkiewicza 19c, 85-065, Bydgoszcz
Osrodek Badan Klinicznych Clinsante s.c. Ewa Galczak-Nowak Malgorzata Trzaska
8511: Cardiology, ul. Konstantego Ildefonsa Galczynskiego 45, 87-100, Torun
Hospital Da Senhora Da Oliveira Guimaraes E.P.E.
2702: Serviço Cardiologia, Rua Dos Cuteleiros De Guimaraes, 4835-044, Guimaraes
Hospital Da Luz S.A.
2710: Serviço Medicina Interna, Avenida Lusiada 100, 1500-650, Lisbon
Unidade Local De Saude De Coimbra E.P.E.
2701: Serviço Cardiologia, Praceta Professor Mota Pinto, 3004-561, Coimbra
Centro Hospitalar De Vila Nova De Gaia/Espinho E.P.E.
2706: Serviço Cardiologia, Rua Conceicao Fernandes S/n, 4434-502, Vila Nova De Gaia
Centro Hospitalar De Tras-Os-Montes E Alto Douro E.P.E.
2703: Serviço Cardiologia, Avenida Da Noruega, 5000-508, Vila Real
Centro Hospitalar De Leiria E.P.E.
2708: Serviço de Cardiologia, Rua Das Olhalvas, 2410-197, Leiria
Unidade Local De Saude De Matosinhos E.P.E.
2707: Serviço Cardiologia, Rua Doutor Eduardo Torres, 4464-513, Senhora Da Hora
Centro Hospitalar De Entre O Douro E Vouga E.P.E.
2709: Serviço Cardiologia, Rua Dr Candido De Pinho, 4520-211, Santa Maria Da Feira
Hospital Garcia De Orta E.P.E.
2705: Serviço Cardiologia, Avenida Torrado Da Silva, 2801-951, Almada
Galo Saude Parcerias Cascais S.A.
2711: Serviço Cardiologia, Avenida Brigadeiro Victor Novais Goncalves, Cobre, Cascais
Centro Hospitalar De Lisboa Ocidental E.P.E.
2700: Serviço Cardiologia, Av Prof Dr Reinaldo Dos Santos, 2790-134, Carnaxide
Unidade Local De Saude De Santa Maria E.P.E.
2704: Serviço Cardiologia, Avenida Professor Egas Moniz, 1649-035, Lisbon
CMI Dr. Podoleanu Cristian, Cabinet Medical de Cardiologie si Medicina Interna
8603: Cardiology, Str. Aleea Cornisa nr. 5, ap. 4, Tg Mures
Centrul Medical De Diagnostic Si Tratament Ambulator Neomed S.R.L.
8615: Cardiology, Block 1 Staircase C Apartment 2 Room 2, Strada Crisului Nr 1, Brasov
Spitalul Municipal Caracal
8619: Cardiology, Strada Plevnei Nr 36, 235200, Caracal
Institutul De Urgenta Pentru Boli Cardiovasculare Prof. Dr. C. C. Iliescu
8612: Cardiology, Soseaua Fundeni 258, 022328, Bucharest
Spitalul Clinic Judetean De Urgenta Craiova
8605: Urology, Strada Tabaci Nr 1, 200642, Craiova
Spitalul Clinic Municipal De Urgenta Timisoara
8620: Cardiology, Bulevardul Revolutiei 1989 Nr 12, 300024, Timisoara
Sana Monitoring S.R.L.
8618: Cardiology, Strada Dr. Sergiu Dumitru No 5, 011025, Bucharest
Cabinet Medical Cardiologie Dr. Mercea Corina Delia
8614: Cardiology, Bd. Independentei 10/43, 430123, Baia Mare
Spitalul Clinic Judetean De Urgenta Bihor
8613: Cardiology, Str Gheorghe Doja Nr 65, 410169, Oradea
Spitalul Judetean De Urgenta Braila
8601: Cardiology, Soseaua Buzaului 2, 810325, Braila
Spitalul Universitar De Urgenta Bucuresti
8609: Cardiologie, Splaiul Independentei 169, 050098, Bucharest
Cabinet Medical Dr Tudoran S.R.L.
8616: Cardiology, Strada Glad No 35a Eftimie Murgu Place No 2, 300480, Timisoara
Cardio Med S.R.L.
8608: Cardiology, Blvd 22 December 1989 No 76, 540124, Targu
Spitalul Clinic De Urgenta Sf. Pantelimon Bucuresti
8611L: Cardiology, Soseaua Pantelimon 340-342, 021661, Bucharest
Medicali's S.R.L.
8607: Cardiology, Strada Cernauti 13, 300362, Timisoara
Spitalul Clinic Municipal De Urgenta Timisoara
8617: Internal Medicine, Strada Dima Gheorghe Nr.5, 300079, Timisoara
Institutul de Boli Cardiovasculare Prof Dr George IM Georgescu Iasi
8602: Cardiology, Bulevardul Carol I Nr 50 Iasi, 700503, Iasi
Elias University Emergency Hospital
8610: Cardiology, Bulevardul Marasti 17, 011461, Bucharest
Sal Med S.R.L.
8604: Cardiology, Block P7 Scara E Etaj P, Strada Traian, Pitesti
University Hospital Bratislava
3020; Kardiologická ambulancia, Ruzinovska 6, Ruzinov, Bratislava
Kardiocentrum Nitra s.r.o.
3015; Kardiologická ambulancia, Spitalska 6, Stare Mesto, Nitra
Zeleznicne zdravotnictvo Kosice s.r.o.
3004: Ambulancia diab. a porúch lát. premeny a výživy, Masarykova 9, Stare Mesto, Kosice
Benimed s.r.o.
3021; Kardiologická ambulancia, Javorova 2882/25, 921 01, Piestany
Medi M&M s.r.o.
3031; Ambulancia vnútorného lekárstva, kardiologická ambulancia, Ceskoslovenskej Armady 35, 045 01, Moldava Nad Bodvou
Stredoslovensky ustav srdcovych a cievnych chorob a.s.
3019; Oddelenie akútnej kardiológie, Cesta K Nemocnici 622/1, 974 01, Banska Bystrica
Medipred s.r.o.
3003: Kardiologická ambulancia, Sv. Jakuba 21, 085 01, Bardejov
University Hospital Bratislava
3030; Kardiologická ambulancia, Mickiewiczova 13, Stare Mesto, Bratislava
Medispol s.r.o.
3005; Ambulancia vnutorného lekárstva, Konstantinova 17, 080 01, Presov
Národny ustav srdcovych a cievnych chorob a.s.
3032; Oddelenie kardiológie a angiológie, Pod Krasnou Horkou 1, Nove Mesto, Bratislava
InterStom s.r.o.
3017; Ambulancia vnútorného lekárstva, Cajkovskeho 2, Klokocina, Nitra
Cardio D&R s.r.o. Kosice
3022; Kardiologická ambulancia, Marsala Koneva 1, Dargovskych Hrdinov, Kosice
Národny ustav srdcovych a cievnych chorob a.s.
3007; Oddelenie akútnej kardiológie - koronárnej starostlivosti, Pod Krasnou Horkou 1, Nove Mesto, Bratislava
Pentes s.r.o.
3026; Kardiologická ambulancia, Halkova 3, 010 01, Zilina
Veria s.r.o.
3018; Kardiologická ambulancia, Svabinskeho 17, 851 01, Petrzalka
Kardio 1 s.r.o.
3001: Kardiologická ambulancia, Namestie Republiky 15 984 01, 98401, Lucenec
Medical group Kosice s.r.o.
3002: Kardiologická ambulancia, Mudronova 29, Juh, Kosice
Tatratrial s.r.o.
3029; Ambulancia diabetológie a porúch látkovej premeny a výživy, Namestie 1. Maja 11, 048 01, Roznava
Medispektrum s.r.o.
3010; Ambulancia vnútorného lekárstva, Gercenova 4/a, 851 01, Petrzalka
Diabeda s.r.o.
3027; Ambulancia diabetológie a porúch látkovej premeny a výživ, Tbiliska 6, Raca, Bratislava
CorArt s.r.o.
3011; Kardiologická ambulancia, Nemocnicna 986/1, 017 01, Povazska Bystrica
Alian s.r.o.
3009; Angiologická ambulancia, Sv. Jakuba 33, 085 01, Bardejov
Imcore s.r.o.
3028; Ambulancia vnútorného lekárstva, Slovenska 86, 080 01, Presov
Kardio-Sanus spol. s r.o.
3006; Kardiologická ambulancia, Stefana Kralika 1 B, 841 07, Devinska Nova Ves
Kardiomed Nz s.r.o.
3016; Kardiologická ambulancia, L. Stura 18, 940 02, Nove Zamky
Národny ustav srdcovych a cievnych chorob a.s.
3008; Ambulantné oddelenie, Pod Krasnou Horkou 1, Nove Mesto, Bratislava
Splosna Bolnisnica Celje
#8701, Oblakova Ulica 5, 3000, Celje
Splosna Bolnisnica Izola Ospedale Generale Isola
#8704, Polje 40, 6310, Izola/isola
Splosna Bolnisnica Dr. Jozeta Potrca Ptuj
#8707, Potrceva Cesta 23, 2250, Ptuj
Univerza V Ljubljani
#8706, Zaloska Cesta 4, 1000, Ljubljana
Splosna Bolnisnica Slovenj Gradec
#8708, Gosposvetska Cesta 1, 2380, Slovenj Gradec
Hospital General Universitario Reina Sofia
3102: medicina interna, Avenida Menendez Pidal S/n, 14004, Cordoba
Instituto Medico Quirurgico San Rafael S.A.
3116: Cardiología, Poboado Nucleo Rural La Jubias 82, 15006, A Coruna
El Hospital Universitario De Gran Canaria Dr. Negrin
3120: Cardiología, Barranco De La Ballena S N, 35010, Las Palmas De Gran Canaria
Hospital Universitario Torrecardenas
3100: Cardiología, Calle Paraje Torrecardenas S/n, 04009, Almeria
Salut Sant Joan De Reus
3113: medicina interna, Avinguda Del Doctor Josep Laporte 2, 43204, Reus
Hospital De Jerez De La Frontera
3146: Cardiología, Carretera De La Ronda Circunvalacion S/n, 11407, Jerez De La Frontera
Complexo Hospitalario Universitario De Santiago
3118: Cardiología, Calle Choupana Da S/n, 15706, Santiago De Compostela
Hospital Universitario Ramon Y Cajal
3144: medicina interna, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital Universitario 12 De Octubre
3124: Cardiología, Bloque D, Avenida De Cordoba Sn, Madrid
Marina Salud S.A.
3109: Cardiología, Partida Beniadla S/n, 03700, Denia
Hospital Universitario Virgen De Valme
3105: medicina interna, Avenida Bellavista S/n, 41014, Sevilla
CAP 17 Setembre
3128: Atención Primaria, C/ Empuries s/n El Prat de Llobregat, 08820, Barcelona
Hospital Universitario Virgen De La Macarena
3106: Cardiología, Avenida Del Doctor Fedriani 3, 41009, Sevilla
Hospital Clinic De Barcelona
3145: Servicio de Cardiología y Medicina Interna, Calle Villarroel 170, 08036, Barcelona
Hospital Quironsalud Barcelona
3131: medicina interna, Placa D'alfonso Comin 5-7, 08023, Barcelona
Hospital Virgen De Las Montanas
3101: medicina interna, Paseo Ambulatorio Sn, 11650, Villamartin
Hospital Son Llatzer
3148: Cardiología, Carretera De Manacor Km 4, 07198, Palma
Hospital General Universitario De Valencia
3139: medicina interna, Avenida Del Tres Cruces 2, 46014, Valencia
Hospital Universitario Clinico San Cecilio
3135: Cardiología, Avenida Del Conocimiento S/n, Poligono Industrial De Ciencias De La Salud, Granada
Hospital Clinico San Carlos
3125: Cardiología, Calle Del Profesor Martin Lagos Sn, 28040, Madrid
Hospital Universitario Fundacion Jimenez Diaz
3122: medicina interna, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Alta Resolución De Utrera
3107: Cardiología, Avda. Brigadas Internacionales, s/n planta 0 bloque 3, Utrera Andalucia
Hospital Universitario De La Princesa
3121: medicina interna, Calle De Diego De Leon 62, 28006, Madrid
Area De Salud De Salamanca
3141: Centro de salud san juan de salamanca, Paseo De San Vicente 55-182, 37007, Salamanca
University Clinical Hospital Virgen De La Arrixaca
3126: Cardiología, Carretera Madrid Cartagena Sn, El Palmar, Murcia
Hospital Clinico Universitario De Valencia
3150: Cardiología, Avenida Blasco Ibanez 17, 46010, Valencia
Bellvitge University Hospital
3112: medicina interna, Carrer De La Feixa Llarga S/n, 08907, L'hospitalet De Llobregat
Hospital De La Santa Creu I Sant Pau
3132: Cardiología, Carrer De San Quinti 89, 08041, Barcelona
Hospital Alvaro Cunqueiro
3119: Cardiología, Estrada Clara Campoamor No 341, 36312, Vigo
Hospital Universitario La Paz
3143: Cardiología, Paseo De La Castellana 261, 28046, Madrid
Parc Tauli Hospital Universitari
3130: Cardiología, Parc Del Tauli 1 Edifici Santa Fe Ala Izquierda Planta 2ª, 08208, Sabadell
University Hospital Virgen Del Rocio S.L.
3149: cardiologia y cirugia cardiovascular, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital La Luz Grupo Quironsalud
3153: Cardiología, Calle Del Maestro Angel Llorca 8, 28003, Madrid
Hospital Universitario Virgen De La Victoria
3104: Cardiología, Calle Del Arroyo Teatinos Sn, 29010, Malaga
Area Sanitaria Da Coruna E Cee
3115: medicina interna, Lugar Jubias De Arriba Num 84, 15006, A Coruna
Equip D'atencio Primaria Barcelona Sardenya S.L.P.
3111: EAP Sardenya, C Sardenya 466, 08025, Barcelona
Hospital Universitario De Salamanca
3137: medicina interna, Paseo De San Vicente 58-182, 37007, Salamanca
Hospital Universitario Marques De Valdecilla
3110: neurologia, Avenida Valdecilla Sn, 39008, Santander
Hospital Unviersitario Miguel Servet
3108: medicina interna, Paseo De Isabel La Catolica 1-3, 50009, Zaragoza
University Hospital Son Espases
3152: Cardiología, Carretera Valldemossa 79, 07120, Palma
Area Sanitaria De Ferrol
3117: Cardiología, Avenida Residencia S/n, 15405, Ferrol
Hospital Infanta Elena
3103: medicina interna, Calle Doctor Pedro Naranjo Sn, 21007, Huelva
Consorci Sanitari Integral
3140: medicina interna, Avinguda De Josep Molins 29-41, 08906, L'hospitalet De Llobregat
Hospital Universitario Fundacion Alcorcon
3129: medicina interna, Calle Budapest 1, 28922, Alcorcon
Hospital Universitario Infanta Sofía
3123: medicina interna, Paseo De Europa 34, 28702, San Sebastian De Los Reyes
Hospital Universitari Vall D Hebron
3133: Cardiología, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Clinico Universitario De Valladolid
3142: endocrinología y nutrición, Avenida Ramon Y Cajal 3, 47003, Valladolid
Hospital Universitario Basurto
3127: Cardiología, Montevideo Etorbidea 16-18, 48013, Bilbao
Hospital General Universitario Gregorio Maranon
3151: endocrinologia y nutrición médica, Calle Del Doctor Esquerdo 46, 28007, Madrid
Area Sanitaria Da Coruna E Cee
3114: Cardiología, Lugar Jubias De Arriba Num 84, 15006, A Coruna
Akardo AB
9010: Cardiology, Lundagatan 23 Nb, Hogalid, Stockholm
Region Vaestmanland
9007: Department of Cardiology, Regionhuset, 721 89, Vasteras
Karolinska University Hospital
9002: Forskningsmottagningen M85, Halsovagen, Flemingsberg, Huddinge
Skånes Universitetssjukhus Malmö
9009: Hjärtmottagningen, Jan Waldenströms gata 15, 20502, Malmö
Falun Hospital, Department of cardiology
9005: Department of Cardiology, Department of Cardiology, Lasarettsvägen 10, Falun
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
9004: Department of Medicine, Research, Diagnosvagen 11, Harlanda, Gothenburg
Region Skane Skanes Universitetssjukhus
9001: Enhet Klinisk Forskning Hjärtmedicin, Entregatan 7, 222 42, Lund
Karolinska University Hospital
9006: Department of Vascular Surgery, Eugeniavagen 3, 171 64, Solna
Medicine Clinic and Research Unit, Carlanderska Hospital
9003: Medicine Clinic and Research Unit, Carlandersparken 1, 405 45, Göteborg
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Austria | 2022-12-12 | 2022-12-12 | 2023-10-21 | ||
| Belgium | 2022-06-07 | 2022-06-07 | 2023-10-21 | ||
| Bulgaria | 2022-04-28 | 2022-04-28 | 2023-10-21 | ||
| Croatia | 2022-03-17 | 2022-03-17 | 2023-10-21 | ||
| Czechia | 2022-05-04 | 2022-05-04 | 2023-10-21 | ||
| Denmark | 2022-05-18 | 2022-05-18 | 2023-10-21 | ||
| Estonia | 2022-03-25 | 2022-03-25 | 2023-10-21 | ||
| Finland | 2022-06-09 | 2022-06-09 | 2023-10-21 | ||
| France | 2021-11-26 | 2021-11-26 | 2023-10-21 | ||
| Greece | 2023-01-31 | 2023-01-31 | 2023-10-21 | ||
| Hungary | 2022-03-03 | 2022-03-03 | 2023-10-21 | ||
| Iceland | 2022-11-09 | 2022-11-09 | 2023-10-21 | ||
| Italy | 2022-01-27 | 2022-01-27 | 2023-10-21 | ||
| Latvia | 2022-04-11 | 2022-04-11 | 2023-10-21 | ||
| Lithuania | 2022-01-10 | 2022-01-10 | 2023-10-21 | ||
| Netherlands | 2022-03-02 | 2022-03-02 | 2023-10-21 | ||
| Norway | 2022-09-12 | 2022-09-12 | 2023-10-21 | ||
| Poland | 2022-06-22 | 2022-06-22 | 2023-10-21 | ||
| Portugal | 2022-01-25 | 2022-01-25 | 2023-10-21 | ||
| Romania | 2022-07-12 | 2022-07-12 | 2023-10-21 | ||
| Slovakia | 2022-01-04 | 2022-01-04 | 2023-10-21 | ||
| Slovenia | 2022-05-25 | 2022-05-25 | 2023-10-21 | ||
| Spain | 2021-12-20 | 2021-12-28 | 2023-10-21 | ||
| Sweden | 2022-05-11 | 2022-05-11 | 2023-10-21 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 179 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol - Signature Page_2024-510735-21-00_1_English_Red | 16Apr2025 |
| Protocol (for publication) | D1_Protocol_2024-510735-21-00 _1_English_Red | 03 |
| Protocol (for publication) | D1_Protocol_2024-510735-21-00 _1_Greek_Red | 03 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_CZ_English_NonRed | NA |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_ES_Spanish_NonRed | 20Jan2025 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_FR_English_Note to Assessor_NonRed | 18Feb2025 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_GR_English_NonRed | 1.1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_IT_English_Note to Assesor_NonRed | 15Apr2025 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_NL_English_Note to Assesor_NonRed | v00 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_NO_English_NonRed | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_NO_English_Note to assessor_NonRed | 23Oct2024 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_PT_English_Note to Assesor_NonRed | 15Nov2024 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_SK_English_NonRed | 08Apr2025 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_Transition Replacement | NA |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements - Country_Transition Replacement | NA |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_Transition Replacement | v5.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_Transition Replacement | v5.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements - Country_Transition Replacement | NA |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_Transition Replacement | v5.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_Transition Replacement | NA |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_Transition Replacement | NA |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_Transition Replacement | v5.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_Transition Replacement | v5.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_Transition Replacement | NA |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_Transition Replacement | NA |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements-Country_Transition Replacement | NA |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements-Country_Transition Replacement | NA |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements-Country_Transition Replacement | NA |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_CZ_Czech_Red | 4.1 |
| Subject information and informed consent form (for publication) | L1_ICF - Additional Biomarkers_1_FR_French_Red | V01.01.02 |
| Subject information and informed consent form (for publication) | L1_ICF - Country - Follow up for pregnant participant_1_BG_NonRed | 1.000 |
| Subject information and informed consent form (for publication) | L1_ICF - Country - Genetics_1_BG_Bulgarian_NonRed | 2.000 |
| Subject information and informed consent form (for publication) | L1_ICF - Country - Main ICF_1_BG_Bulgarian_Red | 4.0 |
| Subject information and informed consent form (for publication) | L1_ICF - Country - Other_1_BG_Bulgarian_Red | 1.000 |
| Subject information and informed consent form (for publication) | L1_ICF - Data Protection - Adult_1_CZ_Czech_Red | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF - Data Protection Adult EU GDPR_1_CZ_Czech_NonRed | 2.0 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_AT_German_NonRed | 1/1/2000 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_EE_Estonian_NonRed | v00.00.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_EE_Russian_NonRed | v00.00.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_ES_Spanish_NonRed | v.00.00.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_FI_Finnish_NonRed | 00.00.02 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_FR_French_NonRed | V00.00.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_GR_English_Red | v00.00.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_GR_Greek_Red | v00.00.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_HR_Croatian_NonRed | v00.00.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_IS_Icelandic_NonRed | 00.00.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_IT_Italian_NonRed | 00.00.02 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_NO_Norwegian_NonRed | v00.00.04 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_PT_Portuguese_NonRed | 01.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_SE_Swedish_NonRed | 1.1 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_SI_Slovenian_NonRed | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_SK_Slovakian_NonRed | V1 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_2_FR_French_NonRed | V00.00.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant partner of participant_1_EE_Estonian_NonRed | v00.00.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant partner of participant_1_EE_Russian_NonRed | v00.00.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant partner of participant_1_ES_Spanish_NonRed | v.00.00.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant partner of participant_1_FI_Finnish_NonRed | 00.00.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant partner of participant_1_HR_Croatian_NonRed | v00.00.02 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant partner of participant_1_IS_Icelandic_NonRed | 00.00.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for Pregnant Partner_1_DK_Danish_NonRed | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant partner_1_SE_Swedish_NonRed | 1.1 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up Pregnant Participant_1_DK_Danish_NonRed | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF - Genetic Research Adult_1_DK_Danish_NonRed | 2.0 |
| Subject information and informed consent form (for publication) | L1_ICF - Genetic Research PIS_1_HU_Hungarian_Red | 2.1 |
| Subject information and informed consent form (for publication) | L1_ICF - Genetic Research_1_BE_Dutch_Red | 1.1 |
| Subject information and informed consent form (for publication) | L1_ICF - Genetic Research_1_BE_English_Red | 1.1 |
| Subject information and informed consent form (for publication) | L1_ICF - Genetic Research_1_BE_French_Red | 1.1 |
| Subject information and informed consent form (for publication) | L1_ICF - Genetic Research_1_CZ_Czech_NonRed | 2.1 |
| Subject information and informed consent form (for publication) | L1_ICF - Genetic Research_1_HU_Hungarian_NonRed | 2.1 |
| Subject information and informed consent form (for publication) | L1_ICF - Genetic Research_2_CZ_Czech_Red | 2.0 |
| Subject information and informed consent form (for publication) | L1_ICF - Genetics_1_AT_German_NonRed | 01.01.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Genetics_1_BG_Bulgarian_Red | 2.000 |
| Subject information and informed consent form (for publication) | L1_ICF - Genetics_1_EE_Estonian_Red | v01.01.03 |
| Subject information and informed consent form (for publication) | L1_ICF - Genetics_1_EE_Russian_Red | v01.01.03 |
| Subject information and informed consent form (for publication) | L1_ICF - Genetics_1_ES_Spanish_Red | v01.01.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Genetics_1_GR_English_Red | v01.01.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Genetics_1_GR_Greek_Red | v01.01.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Genetics_1_HR_Croatian_NonRed | v01.01.03 |
| Subject information and informed consent form (for publication) | L1_ICF - Genetics_1_IT_Italian_NonRed | 01.01.04 |
| Subject information and informed consent form (for publication) | L1_ICF - Genetics_1_LT_Lithuanian_Red | 2.0 |
| Subject information and informed consent form (for publication) | L1_ICF - Genetics_1_LT_Russian_Red | 2.0 |
| Subject information and informed consent form (for publication) | L1_ICF - Genetics_1_LV_Latvian_Red | 2.0 |
| Subject information and informed consent form (for publication) | L1_ICF - Genetics_1_LV_Russian_Red | 2.0 |
| Subject information and informed consent form (for publication) | L1_ICF - Genetics_1_NL_Dutch_NonRed | v01010001 |
| Subject information and informed consent form (for publication) | L1_ICF - Genetics_1_PT_Portuguese_Red | 02.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Genetics_1_RO_Romanian_Red | 2.0 |
| Subject information and informed consent form (for publication) | L1_ICF - Genetics_1_SI_Slovenian_Red | 2.0 |
| Subject information and informed consent form (for publication) | L1_ICF - Genetics_1_SK_Slovakian_NonRed | V1 |
| Subject information and informed consent form (for publication) | L1_ICF - Greenphire_1_FI_Finnish_NonRed | 08.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Info Sheet Female Partner_1_ES_Spanish_NonRed | v.00.00.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Info Sheet Female Partner_1_FI_Finnish_NonRed | 00.00.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Info Sheet Female Partner_1_NO_Norwegian_NonRed | 00.00.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_AT_German_NonRed | 03.03.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_DK_Danish_NonRed | 6.0 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_EE_Estonian_NonRed | 03.03.05 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_EE_Russian_NonRed | 03.03.05 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_ES_Spanish_NonRed | v03.03.05 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_FI_Finnish_NonRed | 03.03.05 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_FR_French_Red | V01.01.02 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_GR_English_Red | v02.02.02 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_GR_Greek_Red | v02.02.02 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_HR_Croatian_NonRed | 03.03.04 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_HU_Hungarian_NonRed | 6.0 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_HU_Hungarian_Red | 6.0 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_IS_Icelandic_NonRed | 03.03.04 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_IT_Italian_Red | 03.03.05 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_NL_Dutch_NonRed | 03030300 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_NO_English_Note to assessor_NonRed | 24Apr2025 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_NO_Norwegian_NonRed | v02.02.05 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_PT_Portuguese_NonRed | V04.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_SE_Swedish_NonRed | 4.0 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_SI_Slovenian_Red | 4.0 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_SK_Slovak_Red | 03.03.04.M |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_2_CZ_Czech_Red | 3.1 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_Addendum_1_FR_French_Red | V02.02.03 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_Addendum_2_FR_French_NonRed | V03.03.04 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF_1_RO_Romanian_NonRed | 4.0 |
| Subject information and informed consent form (for publication) | L1_ICF - Main_1_BE_Dutch_Red | 5.0 |
| Subject information and informed consent form (for publication) | L1_ICF - Main_1_BE_English_Red | 5.0 |
| Subject information and informed consent form (for publication) | L1_ICF - Main_1_BE_French_Red | 5.0 |
| Subject information and informed consent form (for publication) | L1_ICF - Optional Assessment - Coded data_1_HR_Croatian_NonRed | 03.03.04 |
| Subject information and informed consent form (for publication) | L1_ICF - Optional Assessment - Outside activities_1_HR_Croatian_NonRed | 03.03.02 |
| Subject information and informed consent form (for publication) | L1_ICF - Optional Assessment_1_ES_Spanish_Red | v01.00.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Optional Assessment_1_IT_Italian_NonRed | 00.00.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Optional Assessment_1_NL_Dutch_Red | v01010000 |
| Subject information and informed consent form (for publication) | L1_ICF - Other Adult - Optional Off-Site Visit_1_CZ_Czech_NonRed | 2.0 |
| Subject information and informed consent form (for publication) | L1_ICF - Other Adult - Optional Offsite Visit_1_CZ_Czech_Red | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF - Other Adult - Pregnant Participant_1_CZ_Czech_NonRed | 1.1 |
| Subject information and informed consent form (for publication) | L1_ICF - Other Adult_1_HU_Hungarian_Red | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF - Other ICF - Adult Offsite_1_SE_Swedish_NonRed | 2.0 |
| Subject information and informed consent form (for publication) | L1_ICF - Other_1_RO_Romanian_NonRed | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF - Other_Mobile Application_1_LT_Lithuanian_Red | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF - Other_Mobile Application_1_LT_Russian_Red | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF - Pregnant Participant PIS_1_HU_Hungarian_NonRed | 1.1 |
| Subject information and informed consent form (for publication) | L1_ICF - Pregnant Participant_1_BE_Dutch_Red | 1.2 |
| Subject information and informed consent form (for publication) | L1_ICF - Pregnant Participant_1_BE_English_Red | 1.2 |
| Subject information and informed consent form (for publication) | L1_ICF - Pregnant Participant_1_BE_French_Red | 1.2 |
| Subject information and informed consent form (for publication) | L1_ICF - Pregnant Participant_1_HU_Hungarian_NonRed | 1.1 |
| Subject information and informed consent form (for publication) | L1_ICF - Pregnant Partner_1_BE_Dutch_Red | 1.2 |
| Subject information and informed consent form (for publication) | L1_ICF - Pregnant Partner_1_BE_English_Red | 1.2 |
| Subject information and informed consent form (for publication) | L1_ICF - Pregnant Partner_1_BE_French_Red | 1.2 |
| Subject information and informed consent form (for publication) | L1_ICF - Research ICF_1_DK_Danish_NonRed | 2.0 |
| Subject information and informed consent form (for publication) | L1_ICF - Separate Data Protection Consent_1_ES_Spanish_NonRed | 15Apr2024 |
| Subject information and informed consent form (for publication) | L1_ICF - Separate Data Protection Consent_2_ES_Spanish_NonRed | 15Apr2024 |
| Subject information and informed consent form (for publication) | L1_ICF - Separate Data Protection Consent_Core_1_SK_Slovakian_NonRed | 03.03.02.M |
| Subject information and informed consent form (for publication) | L1_ICF - Separate Data Protection Consent_Pregnant_ Patient_1_SK_Slovakian_NonRed | 03.03.02.P |
| Subject information and informed consent form (for publication) | L1_ICF - Subject Information Sheet Female Partner_1_BE_Dutch_Red | 1.1 |
| Subject information and informed consent form (for publication) | L1_ICF - Subject Information Sheet Female Partner_1_BE_English_Red | 1.1 |
| Subject information and informed consent form (for publication) | L1_ICF - Subject Information Sheet Female Partner_1_BE_French_Red | 1.1 |
| Subject information and informed consent form (for publication) | L1_ICF - Subject Participation Card_1_HU_English_Red | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF - Subject Participation Card_1_HU_Hungarian_NonRed | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF Procedure_1_GR_English_NonRed | 1.1 |
| Subject information and informed consent form (for publication) | L1_ICF_Main ICF_1_LT_Lithuanian_Red | 4.0 |
| Subject information and informed consent form (for publication) | L1_ICF_Main ICF_1_LT_Russian_Red | 4.0 |
| Subject information and informed consent form (for publication) | L1_ICF_Main ICF_1_LV_Latvian_Red | 4.0 |
| Subject information and informed consent form (for publication) | L1_ICF_Main ICF_1_LV_Russian_Red | 4.0 |
| Subject information and informed consent form (for publication) | L1_ICF-Country ICF Genetic Research_1_PL_Polish_Red | 2.0 |
| Subject information and informed consent form (for publication) | L1_ICF-Country ICF Main_1_PL_Polish_Red | 5.0 |
| Subject information and informed consent form (for publication) | L1_ICF-Other Pregnant Participant_1_PL_Polish_NonRed | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF-Subject Info Sheet or Other Info_1_AT_German_Red | 6 |
| Subject information and informed consent form (for publication) | L2_ICF - Participant Transfer Authorization Form_1_BG_Bulgarian_NonRed | 3.0 |
| Subject information and informed consent form (for publication) | L2_ICF Procedure_1_ES_Spanish_NonRed | v02 |
| Subject information and informed consent form (for publication) | L2_ICF Procedure_1_FR_English_Note to Assessor_NonRed | 18Feb2025 |
| Subject information and informed consent form (for publication) | L2_ICF Procedure_1_PT_English_NonRed | V01 |
| Subject information and informed consent form (for publication) | L2_Patient Card_1_Czech_NonRed | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_2024-510735-21-00 _1_Norwegian_NonRed | 00 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_2024-510735-21-00_1_Dutch_NonRed | v01 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_2024-510735-21-00_1_English_NonRed | 02 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_2024-510735-21-00_1_French_NonRed | V02 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_2024-510735-21-00_1_Lithuanian_NonRed | v01 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_2024-510735-21-00_1_Slovak_NonRed | v1 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_2024-510735-21-00_1_Swedish_NonRed | v01 |
| Synopsis of the protocol (for publication) | D1_Protocol_Protocol Summary in Technical Language_1_Bulgarian_NonRed | 02 |
| Synopsis of the protocol (for publication) | D1_Protocol_Protocol Summary in Technical Language_1_French_NonRed | V02 |
| Synopsis of the protocol (for publication) | D1_Protocol_Protocol Summary in Technical Language_1_Greek_NonRed | v02 |
| Synopsis of the protocol (for publication) | D1_Protocol_Protocol Summary in Technical Language_1_Italian_NonRed | 02.00 |
| Synopsis of the protocol (for publication) | D1_Protocol_Protocol Summary in Technical Language_1_Portuguese_NonRed | 03 |
| Synopsis of the protocol (for publication) | D1_Protocol_Protocol Summary in Technical Language_1_Spanish_NonRed | v02 |
| Synopsis of the protocol (for publication) | D1_Protocol_Protocol Summary in Technical Language_2024-510735-21-00_1_German_NonRed | v3 |
Application history
17 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-17 | Poland | Acceptable 2024-06-27
|
2024-06-27 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-08-12 | Acceptable | 2024-11-05 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-09-23 | Acceptable | 2024-11-11 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-11-08 | 2025-01-21 | ||
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-01-22 | 2025-01-22 | ||
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-02-21 | Poland | 2025-02-21 | |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-03-20 | Poland | 2025-03-20 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-05-15 | Poland | Acceptable 2025-08-25
|
2025-08-25 |
| 9 | NON SUBSTANTIAL MODIFICATION | NSM-6 | 2025-09-03 | Acceptable 2025-08-25
|
2025-09-03 | |
| 10 | NON SUBSTANTIAL MODIFICATION | NSM-7 | 2025-09-08 | Poland | Acceptable 2025-08-25
|
2025-09-08 |
| 11 | SUBSTANTIAL MODIFICATION | SM-10 | 2025-09-11 | Acceptable | 2025-09-30 | |
| 12 | SUBSTANTIAL MODIFICATION | SM-12 | 2025-09-11 | Acceptable | 2025-11-25 | |
| 13 | SUBSTANTIAL MODIFICATION | SM-11 | 2025-09-12 | Acceptable | 2025-12-08 | |
| 14 | SUBSTANTIAL MODIFICATION | SM-8 | 2025-09-19 | Acceptable | 2025-11-13 | |
| 15 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-09-23 | Acceptable | 2025-12-12 | |
| 16 | SUBSTANTIAL MODIFICATION | SM-9 | 2025-09-24 | Acceptable | 2025-11-04 | |
| 17 | NON SUBSTANTIAL MODIFICATION | NSM-8 | 2026-01-30 | Acceptable | 2026-01-30 |