LIBREXIA-AF A Phase 3 Active-controlled Study of Milvexian for Prevention of Cardioembolic Events in Participants with Atrial Fibrillation

2022-501419-15-00 Protocol 70033093AFL3002 Therapeutic confirmatory (Phase III) Ongoing, recruitment ended

Start 23 Aug 2023 · Status Ongoing, recruitment ended · 19 EU/EEA countries · 372 sites · Protocol 70033093AFL3002

Overview

Sponsor-declared trial summary

Phase Therapeutic confirmatory (Phase III)
Status Ongoing, recruitment ended
Participants planned 19,759
Countries 19
Sites 372

Atrial Fibrillation

To evaluate if milvexian is non-inferior to apixaban for the composite of stroke and non-CNS systemic embolism.

Key facts

Sponsor
Janssen - Cilag International
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Cardiovascular Diseases [C14]
Trial duration
23 Aug 2023 → ongoing
Decision date (initial)
2023-08-07
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
Yes

External identifiers

EU CT number
2022-501419-15-00
ClinicalTrials.gov
NCT05757869

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Pharmacodynamic, Prophylaxis, Pharmacokinetic, Therapy, Efficacy, Pharmacoeconomic

To evaluate if milvexian is non-inferior to apixaban for the composite of stroke and non-CNS systemic embolism.

Secondary objectives 6

  1. To evaluate if milvexian is superior to apixaban in reducing risk of the principal safety endpoint family: • ISTH major bleeding • Composite of ISTH major and CRNM bleeding
  2. To evaluate if milvexian is superior to apixaban as assessed by the composite of the primary efficacy endpoint and the principal safety endpoint.
  3. To evaluate if milvexian is superior to apixaban for the composite of CV death, MI, stroke and non-CNS systemic embolism.
  4. To evaluate if milvexian is superior to apixaban as assessed by CV death.
  5. To evaluate if milvexian is superior to apixaban as assessed by the composite of all-cause death, MI, stroke and non-CNS systemic embolism.
  6. To evaluate if milvexian is superior to apixaban as assessed by the composite of CV death, MI, stroke, acute limb ischemia (ALI [any unanticipated revascularization or amputation of ischemic limb]), and urgent hospitalization for vascular cause of ischemic nature (including thrombotic events: deep vein thrombosis [DVT] and pulmonary embolism [PE]).

Conditions and MedDRA coding

Atrial Fibrillation

VersionLevelCodeTermSystem organ class
20.0 PT 10003658 Atrial fibrillation 100000004849

Regulatory references

Scientific advice from competent authorities
European Medicines Agency
Plan to share IPD
Yes
IPD plan description
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

  1. Minimum age of 18 years
  2. Medically stable and appropriate for chronic antithrombotic treatment
  3. Atrial fibrillation eligible to receive anticoagulation therapy.
  4. Participant must satisfy one or both of the following categories of risk factors (a or b): a. One or more of the following risk factors: i. Age ≥75 years ii. History of any type of stroke, including symptomatic stroke of any kind and silent brain infarcts or cerebral microbleeds b. Two or more of the following risk factors: i. Age between 65 and 74 years ii. Hypertension iii. Diabetes mellitus iv. Atherosclerotic vascular disease v. Heart Failure

Exclusion criteria 2

  1. Hemodynamically significant valve disease or those with valve disease that will potentially require surgical valve replacement during the study
  2. Any condition other than AF that requires chronic anticoagulation

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. Time to the first occurrence of composite endpoint of stroke and non-CNS systemic embolism

Secondary endpoints 6

  1. • Time to the first occurrence of ISTH major bleeding • Time to the first occurrence of the composite of ISTH major and CRNM bleeding
  2. Time to the first occurrence of composite endpoint of stroke, non-CNS systemic embolism, and ISTH major bleeding.
  3. Time to the first occurrence of composite endpoint of CV death, MI, stroke, and non-CNS systemic embolism.
  4. Time to CV death
  5. Time to the first occurrence of composite endpoint of all-cause death, MI, stroke and non-CNS systemic embolism.
  6. Time to the first occurrence of composite endpoint of CV death, MI, stroke, acute limb ischemia (ALI [any unanticipated revascularization or amputation of ischemic limb]), and urgent hospitalization for vascular cause of ischemic nature (including DVT and PE).

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

JNJ-70033093

PRD10075928 · Product

Active substance
Milvexian
Substance synonyms
BMS986177, BMS-986177, (5R,9S)-9-{4-[5-chloro-2-(4-chloro-1H-1,2,3-triazol-1-yl)phenyl]-6-oxopyrimidin-1(6H)-yl}-22-(difluoromethyl)-5-methyl-22H-3-aza-1(4,2)-pyridina-2(3,4)-pyrazolacyclononaphan-4-one, JNJ-70033093
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL
Max daily dose
200 mg milligram(s)
Max total dose
292000 mg milligram(s)
Max treatment duration
48 Month(s)
Authorisation status
Not Authorised
MA holder
JANSSEN-CILAG INTERNATIONAL N.V.
Paediatric formulation
No
Orphan designation
No

Comparator 4

Eliquis 5 mg film-coated tablets

PRD2351268 · Product

Active substance
Apixaban
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL
Max daily dose
10 mg milligram(s)
Max total dose
14600 mg milligram(s)
Max treatment duration
48 Month(s)
Authorisation status
Authorised
ATC code
B01AF02 — -
Marketing authorisation
EU/1/11/691/012
MA holder
BRISTOL-MYERS SQUIBB/PFIZER EEIG
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
Yes
Modification description
The film-coated tablets will be supplied as over-encapsulated capsules.

Eliquis 5 mg film-coated tablets

PRD2351289 · Product

Active substance
Apixaban
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL
Max daily dose
10 mg milligram(s)
Max total dose
14600 mg milligram(s)
Max treatment duration
48 Month(s)
Authorisation status
Authorised
ATC code
B01AF02 — -
Marketing authorisation
EU/1/11/691/011
MA holder
BRISTOL-MYERS SQUIBB/PFIZER EEIG
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
Yes
Modification description
The film-coated tablets will be supplied as over-encapsulated capsules.

Eliquis 2.5 mg film-coated tablets

PRD1722226 · Product

Active substance
Apixaban
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL
Max daily dose
5 mg milligram(s)
Max total dose
7300 mg milligram(s)
Max treatment duration
48 Month(s)
Authorisation status
Authorised
ATC code
B01AF02 — -
Marketing authorisation
EU/1/11/691/015
MA holder
BRISTOL-MYERS SQUIBB/PFIZER EEIG
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
Yes
Modification description
The film-coated tablets will be supplied as over-encapsulated capsules.

Eliquis 2.5 mg film-coated tablets

PRD2351318 · Product

Active substance
Apixaban
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL
Max daily dose
5 mg milligram(s)
Max total dose
7300 mg milligram(s)
Max treatment duration
48 Month(s)
Authorisation status
Authorised
ATC code
B01AF02 — -
Marketing authorisation
EU/1/11/691/013
MA holder
BRISTOL-MYERS SQUIBB/PFIZER EEIG
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
Yes
Modification description
The film-coated tablets will be supplied as over-encapsulated capsules.

Placebo 2

Apixaban matching placebo

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

Milvexian matching placebo

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 3

Ondexxya 200 mg powder for solution for infusion

PRD9745324 · Product

Active substance
Andexanet Alfa
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS
Max daily dose
1760 mg milligram(s)
Max total dose
1760 mg milligram(s)
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
V03AB38 — -
Marketing authorisation
EU/1/18/1345/001
MA holder
ASTRAZENECA AB
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Eliquis 5 mg film-coated tablets

PRD2351290 · Product

Active substance
Apixaban
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL
Max daily dose
10 mg milligram(s)
Max total dose
300 mg milligram(s)
Max treatment duration
30 Day(s)
Authorisation status
Authorised
ATC code
B01AF02 — -
Marketing authorisation
EU/1/11/691/009
MA holder
BRISTOL-MYERS SQUIBB/PFIZER EEIG
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Eliquis 2.5 mg film-coated tablets

PRD2351250 · Product

Active substance
Apixaban
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL
Max daily dose
5 mg milligram(s)
Max total dose
150 mg milligram(s)
Max treatment duration
30 Day(s)
Authorisation status
Authorised
ATC code
B01AF02 — -
Marketing authorisation
EU/1/11/691/003
MA holder
BRISTOL-MYERS SQUIBB/PFIZER EEIG
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Janssen - Cilag International

109 Total trials 22 Recruiting 86 Ended
Commercial
Sponsor organisation
Janssen - Cilag International
Address
Turnhoutseweg 30
City
Beerse
Postcode
2340
Country
Belgium

Scientific contact point

Organisation
Janssen - Cilag International
Contact name
CTIS Point of Contact

Public contact point

Organisation
Janssen - Cilag International
Contact name
CTIS Point of Contact

Third parties 11

OrganisationCity, countryDuties
Eresearchtechnology Inc.
ORG-100013039
 Philadelphia, United States Other
Cisys Inc.
ORG-100046011
 Raleigh, United States Other
Iqvia Limited
ORG-100008655
 Reading, United Kingdom On site monitoring, Code 10, Code 12, Code 13, Code 2, Code 5, Code 8, Code 9
Olink Proteomics AB
ORG-100045757
 Uppsala, Sweden Laboratory analysis
Pharmaceutical Research Associates Group B.V.
ORG-100006268
 Assen, Netherlands Laboratory analysis
IQVIA RDS Hellas Single Member S.A
ORL-000000587
 Athens, Greece On site monitoring, Code 12, Code 8
Medidata Solutions Inc.
ORG-100016256
 New York, United States E-data capture
Omnitrace Corp.
ORG-100045579
 Palm Beach Gardens, United States Other
Olink Proteomics Inc.
ORG-100046440
 Waltham, United States Laboratory analysis
Almac Clinical Technologies LLC
ORG-100043036
 Souderton, United States Interactive response technologies (IRT)
Labcorp Central Laboratory Services S.a.r.l. Meyrin
ORG-100011524
 Meyrin, Switzerland Laboratory analysis

Locations

19 EU/EEA countries · 372 investigational sites

By country

CountryMS statusPlanned subjectsSites
Belgium Ongoing, recruitment ended 109 13
Bulgaria Ongoing, recruitment ended 1,348 37
Croatia Ongoing, recruitment ended 110 11
Czechia Ongoing, recruitment ended 687 30
Denmark Ongoing, recruitment ended 178 9
Estonia Ongoing, recruitment ended 34 1
France Ongoing, recruitment ended 103 15
Germany Ongoing, recruitment ended 656 41
Greece Ongoing, recruitment ended 52 11
Hungary Ongoing, recruitment ended 1,090 34
Italy Ongoing, recruitment ended 279 20
Latvia Ongoing, recruitment ended 26 3
Lithuania Ongoing, recruitment ended 182 8
Netherlands Ongoing, recruitment ended 369 23
Poland Ongoing, recruitment ended 1,982 56
Portugal Ongoing, recruitment ended 115 8
Romania Ongoing, recruitment ended 330 17
Slovakia Ongoing, recruitment ended 399 19
Spain Ongoing, recruitment ended 190 16
Rest of world
China, New Zealand, Israel, Malaysia, India, Singapore, Brazil, South Africa, United Kingdom, Chile, Serbia, Turkey, Korea, Republic of, Japan, Argentina, Taiwan, Philippines, Canada, Australia, United States
 — 11,520 —

Investigational sites

Belgium

13 sites · Ongoing, recruitment ended
Centre hospitalier universitaire de Tivoli Institut medical des Mutualites socialistes
Cardiology, Avenue Max Buset 34, 7100, La Louviere
UZ Leuven
Cardiology, Herestraat 49, 3000, Leuven
Hopital Erasme
Cardiology, Lennikse Baan 808, 1070, Anderlecht
Cliniques du Sud-Luxembourg
Cardiology, Rue des Déportés 137, 6700, Arlon
A.Z. Sint-Maarten
Cardiology, Liersesteenweg 435, 2800, Mechelen
Heilig Hartziekenhuis Mol
Cardiology, Gasthuisstraat 1, 2400, Mol
Jessa Ziekenhuis
Cardiology, Stadsomvaart 11, 3500, Hasselt
Az Delta
Cardiology, Deltalaan 1, 8800, Roeselare
Azorg
Cardiology, Moorselbaan 164, 9300, Aalst
Chu Brugmann
Cardiology, Arthur Van Gehuchtenplein 4, 1020, Brussels
O.L.Vrouw van Troost
Cardiology, Kroonveldlaan 50, 9200, Dendermonde
Antwerp University Hospital
Cardiology, Drie Eikenstraat 655, 2650, Edegem
Ziekenhuis Aan De Stroom
Cardiology, Lindendreef 1, 2020, Antwerp

Bulgaria

37 sites · Ongoing, recruitment ended
Multiprofile Hospital For Active Treatment Dr. Tota Venkova AD
Department of Cardiology, Iliev Detskiya Str 1 Dr, 5300, Gabrovo
Multiprofile Hospital For Active Treatment Knyaginya Klementina Sofia EAD
Department of cardiology, Bulevard Gen. Stoletov No 67a, 1233, Sofiya
Umbal - Prof. D-R Stoyan Kirkovich AD
Clinic of cardiology, Ulitsa General Stoletov 2, 6003, Stara Zagora
Asclepius Medical Center OOD
N/A, Ploshtad Svoboda 1, 2600, Dupnitsa
Diamedical Medical Center 2013 Ltd.
N/A, Ulitsa Lyuben Karavelov 22, 6400, Dimitrovgrad
Multiprofile Hospital For Active Treatment St. Panteleimon Yambol AD
First Department for Internal Diseases, Ulitsa Panayot Hitov 30, 8600, Yambol
Medical center 4LIFE Ltd.
N/A, Zornitsa Bl No 61, Fl 1, Burgas
University Multiprofile Hospital For Active Treatment Saint Georgi EAD
Clinic of cardiology, Bulevard Peshtersko Shose 66, 4002, Plovdiv
Medical Center Hera EOOD
N/A, Ulitsa Klisura 20, 1510, Sofiya
Medical Center Izgrev EOOD
N/A, Bl 56, Entrance 1 Fl 14, Sofia
Diagnostics And Consultation Center Convex Ltd.
N/A, Ulitsa Sinanishko Ezero 11a, 1680, Sofiya
Multidisciplinary Hospital For Active Treatment Haskovo AD
Department of cardiology, Bulevard Siedinenie 49, 6304, Haskovo
Medical Center Zara-Med EOOD
N/A, Ulitsa Orfey 4, 6003, Stara Zagora
Ambulatory for Individual Practice for Specialized Medical Care in Cardiology - Dr Nikolay Iliev
N/A, 13, Hristo Yasenov Str., Pleven
Medical Center Medica Plus Ltd.
N/A, Ulitsa Sergey Rumyantsev 63, 5006, Veliko Tirnovo
Uniteversity Muliprofile Hospital For Active Treatment Tsaritsa Yoanna-Isul EAD
Clinic of cardiology, Oborishte Distr., Ul.Byalo More 8, Sofia
UMHAT Pulmed OOD – branch Medical structure Zdrave
Department of Internal Diseases, 50, Konstantin Velichkov Str., Pazardzhik
National Multidisciplinary Transport Hospital Tsar Boris III
Clinic of Cardiology, Bulevard Knyaginya Mariya Luiza 104, 1233, Sofia
Second Multiprofile Hospital For Active Treatment - Sofia EAD
Clinic of cardiology, Bulevard Hristo Botev 120, 1202, Sofiya
University Hospital St. Anna
Clinic of internal diseases, Ulitsa Dimitir Mollov 1, 1750, Sofiya
Multi-profile Hospital for Active Treatment Heart and Brain EAD
Clinic of cardiology, Pierre Curie Street 2, 5804, Pleven
Medical Center Prolet EOOD
N/A, Ulitsa Olimpi Panov 25, 7000, Ruse
UNIMED Medical Center EOOD
N/A, Ulitsa Nikola D. Petkov 30, 5403, Sevlievo
Ambulatory for Individual Practice for Specialized Medical Care in Internal Diseases and Cardiology
N/A, 28, Tzar Asen Str., Sofia
Diagnostic Consultative Centre Ascendent OOD
N/A, Ul.bacho Kiro 47, 1202, Sofia
Multiprofile Regional Hospital For Active Treatment Dr. Stefan Cherkezov AD
Department of cardiology, Ulitsa Nish 1, 5002, Veliko Tirnovo
University Multiprofile Hospital For Active Treatment Dr. Georgi Stranski EAD
Clinic of Cardiology, Ulitsa Georgi Kochev 8-A, 5803, Pleven
Acibadem City Clinic Tokuda University Hospital EAD
Clinic of cardiology, Bulevard Nikola Yonkov Vaptsarov 51b, 1407, Sofiya
Medical Center Rusemed EOOD
N/A, Floor 5, Bulevard Lipnik 123, Ruse
MHAT National Heart Hospital EAD
Clinic of cardiology, Ulitsa Konyovitsa 65, 1309, Sofiya
Multiprofile Hospital For Active Treatment Sveta Ekaterina-Dimitrovgrad EOOD
Department of Internal Diseases, Bulevard Hristo Botev 29, 6400, Dimitrovgrad
Medical Center Medconsult Pleven OOD
N/A, Floor 4, Ulitsa Sveti Sveti Kiril I Metodiy 18, Pleven
Diagnostic-Consultative Center Alexandrovska EOOD
N /A, Triaditsa, Ulitsa Sveti Georgi Sofiyski 1, Sofiya
Diagnostic-Consultative Center Alexandrovska EOOD
N/A, Triaditsa, Ulitsa Sveti Georgi Sofiyski 1, Sofiya
Kalimat Medical Center Ltd.
N/A, Ulitsa Yastrebets 11, 1680, Sofia
University Multidisciplinary Hospital for Active Treatment Sveta Ekaterina EAD
Clinic of cardiology, Bulevard Pencho Slaveykov 52a, 1431, Sofia
Medical Center Rodopimed EOOD
N/A, Ulitsa Osogovo 8, 6600, Kirdzhali

Croatia

11 sites · Ongoing, recruitment ended
Specijalna Bolnica Za Medicinsku Rehabilitaciju Krapinske Toplice
cardiology, Ulica Ljudevita Gaja 2, 49217, Krapinske Toplice
Zupanijska Bolnica Cakovec
cardiology, I. G. Kovacica 1e, 40000, Cakovec
General hospital Karlovac
cardiology, Andrije Stampara 3, 47000, Karlovac
Clinic for Cardiovascular Medicine Magdalena
cardiology, Ul. Ljudevita Gaja 2, Croatia
Opca Bolnica Varazdin
cardiology, Ulica Ivana Mestrovica 1, 42000, Varazdin
Poliklinika Solmed d.o.o.
cardiology, Preradoviceva Ulica 20, Zagreb, Grad Zagreb
Opca Bolnica Zadar
Cardiology, Ulica Boze Pericica 5, 23000, Zadar
Poliklinika BONIFARM
department for clinical research, Ulica Aleksandra Hondla 2/11, Zagreb, Grad Zagreb
Opca Bolnica Dubrovnik
cardiology, Dr. Roka Misetica 2, 20000, Dubrovnik
Clinical Hospital Dubrava
cardiology, Avenija Gojka Suska 6, Zagreb, Grad Zagreb
Opca Bolnica Varazdin
neurology, Ulica Ivana Mestrovica 1, 42000, Varazdin

Czechia

30 sites · Ongoing, recruitment ended
Fakultni Nemocnice U Sv Anny V Brne
I. interni kardioangiologicka klinika, Pekarska 53, Stare Brno, Brno-Stred
Interni Ordinace s.r.o.
NA, Jiriho Wolkera 603/1, 250 01, Brandys Nad Labem
Ustredni Vojenska Nemocnice Vojenska Fakultni Nemocnice Praha
Kardiologicke oddeleni, U Vojenske Nemocnice 1200, 169 02, Prague 6
Fakultni Nemocnice Plzen
Kardiologicka klinika, Alej Svobody 923/80, 323 00, Plzen 23
Ordinace pro choroby srdce s.r.o.
NA, Vilema Blodka 5683, 430 01, Chomutov
Edumed s.r.o.
NA, Smetanova 91, 550 01, Nove Mesto
Vojenska Nemocnice Brno
Interni oddeleni, Zabrdovicka 3, Zabrdovice, Brno-Zidenice
MUDr. Nina Zemkova s.r.o.
NA, Masarykovo Namesti 155, 686 01, Uherske Hradiste
ROcardia s.r.o.
NA, Lomena 4572/4, 796 04, Prostejov
Vseobecna Fakultni Nemocnice V Praze
II. interni klinika, U Nemocnice 499/2, Nove Mesto, Prague 2
MUDr. Zdenek Vomacka kardiologie a interna s.r.o.
NA, Cajkovskeho 67/14, 779 00, Nova Ulice
Cardio Research s.r.o.
NA, J. A. Bati 5645, 760 01, Zlin
Kardiologie a angiologie s.r.o.
NA, Turkmenska 1417/8, Vrsovice, Prague
MUDr. Hana Burianova
NA, Nova cesta 531/11, 74301, Bilovec
Fakultni Nemocnice Kralovske Vinohrady
Kardiologicka klinika, Srobarova 1150/50, Vinohrady, Prague 10
MUDr. Petra Maskova, PhD.
NA, Vitezna 173/1A, Czechia, Litovel
Kardiologicka ambulance MUDr. Ferkl s.r.o.
NA, Palackeho 201, 541 01, Horni Predmesti
Medicus Services s.r.o.
NA, Nadrazni 1317/5, 250 01, Brandys Nad Labem
Lunacor spol. s r.o.
NA, Komenskeho Namesti 372/14, 767 01, Kromeriz
Nemocnice Na Frantisku
Interni oddeleni, Na Frantisku 847/8, Stare Mesto, Prague 1
Nemocnice Pardubickeho kraje a.s.
Interni oddeleni, Kyjevska 44, 532 03, Pardubice
Nemocnice Ceske Budejovice a.s.
Kardiologie, B. Nemcove 585/54, 370 01, Ceske Budejovice 7
Cerebrovaskularni poradna s.r.o.
NA, Musorgskeho 1029/9, Moravska Ostrava, Moravska Ostrava A Privoz
Kardiologicka ambulance s.r.o.
NA, Cechovska 57, 261 01, Pribram VIII
Corintez s.r.o.
NA, Seydlerova 2451, 158 00, Prague 13
Preventamed s.r.o.
NA, Domovina 774/2, 779 00, Olomouc
Kardiologie KarMa s.r.o.
NA, Pulecny 184, 468 02, Pulecny
Nemocnice Slany
Interni oddeleni, Politickych Veznu 576, 274 01, Slany
MUDr. Jan Hubac s.r.o.
NA, Masarykovo Namesti 55, 537 01, Chrudim IV
Fakultni Nemocnice Motol A Homolka
Interni klinika, V Uvalu 84/1, Motol, Prague

Denmark

9 sites · Ongoing, recruitment ended
Hvidovre Hospital
Department of Cardiology, Kettegaard Alle 30, 2650, Hvidovre
Odense University Hospital
Internal Medicine and Emergency Department, Baagoees Alle 15, 5700, Svendborg
Slagelse Hospital
Department of Cardiology, Ingemannsvej 18, 4200, Slagelse
Region Sjaelland
Department of Cardiology, Sygehusvej 10, 4000, Roskilde
Herlev Hospital
Department of Cardiology, Herlev Ringvej 75, 2730, Herlev
Holbaek Sygehus
Department of Internal Medicine, Smedelundsgade 60, 4300, Holbæk
Aarhus University Hospital
Department of Cardiology, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N
Amager Hospital
Cardiology Department, Italiensvej 1, 2300, Copenhagen S
Regionshospitalet Godstrup
Department of Cardiology, Hospitalsparken 15, 7400, Herning

Estonia

1 site · Ongoing, recruitment ended
Dr Arvo Rosenthal OÜ
N/A, J Sutiste Tee 19a-198 Korpus, 13419, Tallinn

France

15 sites · Ongoing, recruitment ended
Assistance Publique Hopitaux De Paris
Cardiology, 46 Rue Henri Huchard, 75877, Paris Cedex 18
Assistance Publique Hopitaux De Paris
Cardiology, 51 Avenue Du Mal De Lattre De Tassigny, 94010, Creteil Cedex
Polyclinique Vauban
Cardiologie, 10 Avenue Vauban, 59300, Valenciennes
Centre Hospitalier Universitaire De Poitiers
Cardiology, 2 Rue De La Miletrie, 86000, Poitiers
CHU De Rouen
Cardiologie, 1 Rue De Germont, Bp 96031, Rouen Cedex
Centre Hospitalier De Pau
Cardiology, 4 Boulevard Hauterive, Cs 17595, Pau Cedex
Centre Hospitalier Universitaire D Angers
Cardiology, 4 Rue Larrey, 49933, Angers Cedex 9
Hospices Civils De Lyon
Cardiology, 28 Avenue Du Doyen Jean Lepine, 69500, Bron
Centre Hospitalier De La Cote Basque
Cardiology, 13 Avenue Interne Jacques Loeb, 64100, Bayonne
Assistance Publique Hopitaux De Paris
Cardiology, 2 Rue Ambroise Pare, 75010, Paris
Centre Hospitalier Universitaire De Dijon
Cardiology, 14 Rue Paul Gaffarel, 21000, Dijon
Assistance Publique Hopitaux De Paris
Cardiology, 184 Rue Du Faubourg Saint Antoine, 75012, Paris
Clinique Saint Hilaire
Cardiology, 2 Place Saint Hilaire, 76000, Rouen
Hospital De La Cavale Blanche
Cardiology, Boulevard Tanguy Prigent, 29200, Brest
Assistance Publique Hopitaux De Paris
Cardiology, 54 56 Rue Pascal 54a, 75013, Paris

Germany

41 sites · Ongoing, recruitment ended
Zentrum fuer klinische Studien Suedbrandenburg GmbH
N/A, Bahnhofstrasse 22, 04910, Elsterwerda
Asklepios Kliniken Hamburg GmbH
Kardiologie und internistiche Intensivmedizin, Paul-Ehrlich-Strasse 1, Othmarschen, Hamburg
Gemeinschaftspraxis Dr. med. Haggenmiller/Prof. Dr. med. Michael Jeserich
N/A, Königstrasse 39, 90402, Nürnberg
Studienzentrum Bocholderstrasse
N/A, Bocholder Str. 158, 45355, Essen
Vivantes Netzwerk fuer Gesundheit GmbH
Kardiologie und konservative Intensivmedizin, Am Nordgraben 2/1, Wittenau, Berlin
Städtisches Klinikum Dresden
N/A, Friedrichstraße 41, 01067, Dresden
University Medical Centre Schleswig-Holstein
Klinik für Innere Medizin III, Arnold-Heller-Strasse 3, Brunswik, Kiel
SANA Kliniken Oberfranken Coburg GmbH
Kardiologie, Ketschendorfer Strasse 33, 96450, Coburg
Medical Center - University Of Freiburg
Universitäts-Herzzentrum, Klinik für Kardiologie und Angiologie, Hugstetter Strasse 55, Stuehlinger, Freiburg Im Breisgau
Marienhaus Klinikum St. Elisabeth Neuwied
Klinik für Innere Medizin - Kardiologie/Rhythmologie, Friedrich-Ebert-Strasse 59, 56564, Neuwied
ClinPhenomics CVC GmbH
N/A, Schaumainkai 101-103, Sachsenhausen, Frankfurt Am Main
Hausaerztlich-Kardiologisches MVZ Am Felsenkeller GmbH
N/A, Haus A, Enderstrasse 59, Dresden
Klinikum Altenburger Land GmbH
Klinik für Neurologie, Am Waldessaum 10, 04600, Altenburg
Praxis Dr. med. Cornelia Brauer
N/A, Tangstedter Landstraße 77, 22415, Hamburg
Medizentrum Essen Borbeck
N/A, Huelsmannstrasse 6, Borbeck, Essen
Marienhaus Kliniken GmbH
Innere Medizin I - Kardiologie, An Der Goldgrube 11, Oberstadt, Mainz
Kardiologische Praxis
N/A, Clara-Zetkin-Strasse 23, 04779, Wermsdorf
Charite Universitaetsmedizin Berlin KöR
Klinik für Kardiologie, Angiologie und Intensivmedizin, Hindenburgdamm 30, Lichterfelde, Berlin
Kardiogische Praxis Papenburg
N/A, Kirchstrasse 9, 26871, Papenburg
ze:ro Praxen MVZ fuer Nierenerkrankungen und Bluthochdruck GmbH Mannheim
Praxis für Innere Medizin, Kardiologie, Angiologie, Pneumologie und Allergologie, Georg-Lechleiter-Platz 3, Schwetzingerstadt, Mannheim
CIMS Studienzentrum Bamberg GmbH
N/A, Buger Strasse 82, Berg, Bamberg
B. Braun Ambulantes Herzzentrum Kassel MVZ GmbH
N/A, Bergmannstrasse 28, Wehlheiden, Kassel
Medizinisches Versorgungszentrum Jung GbR
N/A, Ditzenbacher Strasse 33, 73326, Deggingen
Evangelisches Krankenhaus Witten gGmbH
N/A, Pferdebachstrasse 27-43, Mitte, Witten
Asklepios Klinik St George
Medizinische Versorgungszentrum Prof. Mathey, Prof. Schofer GmbH, Lohmuehlenstrasse 5, St. Georg, Hamburg
Asklepios Klinik St George
Kardiologie und Internistische Intensivmedizin, Lohmuehlenstrasse 5, St. Georg, Hamburg
Gemeinnuetzige Gesellschaft Der Franziskanerinnen Zu Olpe mbH
Betriebsstätte St. Marien Hospital, Robert-Koch-Strasse 1, Venusberg, Bonn
Klinikum der Stadt Ludwigshafen am Rhein gGmbH
Medizinische Klinik B, Herzzentrum, Bremserstrasse 79, Friesenheim, Ludwigshafen Am Rhein
Kardiologische Praxis Dr. med. univ. Wolfgang Jungmair
Kardiopraxis Bad Homburg, Louisenstr. 63, 61348, Bad Homburg
Klinikum Bielefeld gGmbH
Abteilung für Kardiologie und internistische Intensivmedizin, Teutoburger Strasse 50, Innenstadt, Bielefeld
Vivantes Netzwerk fuer Gesundheit GmbH
Klinik für Innere Medizin - Kardiologie und konservative Intensivmedizin, Landsberger Allee 49, Friedrichshain, Berlin
Klinikum am Plattenwald
N/A, Am Plattenwald 1, 74177, Bad Friedrichshall
Kardiologische Praxen im Spreebogen
N/A, Alt-Moabit 101b, 10559, Berlin
Klinikum Worms gGmbH
Medizinische Klinik I - Kardiologie und Angiologie, Gabriel-Von-Seidl-Strasse 81, Herrnsheim, Worms
Facharztzentrum Dresden-Neustadt Betriebsgesellschaft mbH
N/A, Forststrasse 3, Radeberger Vorstadt, Dresden
Universitaetsklinikum Tuebingen AöR
Medizinische Klinik II - Kardiologie und Angiologie, Otfried-Mueller-Strasse 10, Nordstadt, Tuebingen
Klinisches Forschungszentrum Dr. Hagemann am Hausarztzentrum am Germaniaplatz
N/A, Germaniaplatz 8, 45355, Essen
Praxisgemeinschaft Stuhr-Brinkum
N/A, Melcherstätte 7, 28816, Stuhr
Vivantes Netzwerk fuer Gesundheit GmbH
Kardiologie, Allg. Medizin und kons. Intensivmedizin, Dieffenbachstrasse 1/1, Kreuzberg, Berlin
Herz Und Diabeteszentrum NRW Universitaetsklinik Der Ruhr Universitaet Bochum
Klinik für Electrophysiologie/Rhythmologie, Georgstrasse 11, Innenstadt, Bad Oeynhausen
Vivantes Netzwerk fuer Gesundheit GmbH
Klinik für Innere Medizin und Kardiologie, Myslowitzer Strasse 45, Kaulsdorf, Berlin

Greece

11 sites · Ongoing, recruitment ended
General Hospital Of Thessaloniki Papageorgiou
3rd Department of Internal Medicine, Ring Road Of Thessaloniki, Ministry Of Pavlos Melas, Efkarpia
General Hospital Of Thessaloniki Papageorgiou
B’ Cardiology Clinic, Ring Road Of Thessaloniki, Ministry Of Pavlos Melas, Efkarpia
University General Hospital Attikon
B’ Department of Cardiology, Rimini Street 1, 124 62, Athens
General Hospital Of Nea Ionia Konstantopouleio Patision
Cardiology Clinic, Konstadopoulou Th. 3-5, 142 33, Nea Ionia
General University Hospital Of Patras
Cardiology Clinic, Rio, 265 04, Patras
Hippokration Hospital
1st Cardiology Clinic, Vassilissas Sofias Avenue 114, 115 27, Athens
Athens Euroclinic S.A.
B Cardiac Department, Athanassiadou 7-9, 115 21, Athens
General Hospital Of Athens G Gennimatas
Cardiology Department, Messogion Avenue 154, 115 27, Athens
University General Hospital Of Alexandroupoli
Cardiology Department, 6th Km Alex Polis Makris, Dragana, Alexandroupoli
Geniko Nosokomeio Thessalonikis George Papanikolaou
Department of Cardiology, Exochi, 570 10, Thessaloniki
Onassis Cardiac Surgery Center
Cardiac Pacing and Electrophysiology, 356, Leoforos Andrea Siggrou 356, 176 74, Kallithea

Hungary

34 sites · Ongoing, recruitment ended
University Of Szeged
Szent-Györgyi Albert Klinikai Központ, Családorvosi Intézet és Rendelő, Semmelweis Utca 8, 6725, Szeged
Buda Hospital Of The Hospitaller Order Of Saint John Of God
Kardiológia, Arpad Fejedelem Utja 7/II, II Kerulet, Budapest II
Dr. Nagy László Kardiológiai Magánrendelés
N/A, Kígyó u. 24., 5900, Orosháza
Med-Tima Kft.
N/A, Gyongyhaz Utca 2/I./em. 4, XIII Kerulet, Budapest XIII
Clinexpert Kft.
-, Kaszasdulo Utca 5, 1033, Budapest III
IPR Hungary Kft.
N/A, Erzsebet Ter 1, 3530, Miskolc
Semmelweis University
Városmajori Szív és Érgyógyászati Kl. Kard. Rehab., Gyulai Pal Utca 2, Kerulet, Budapest VIII
TaNa Med Kft.
N/A, Hunyadi Janos Utca 14, 9200, Mosonmagyarovar
Obudai Egeszsegugyi Centrum Kft.
N/A, Lajos Utca 74-76, 1036, Budapest III
BKS Research Kft.
N/A, Balassi Balint Ut 16, 3000, Hatvan
University Of Debrecen
Belgyógyászati Klinika, A épület, Nagyerdei Korut 98, 4032, Debrecen
Coromed-Smo Kft.
N/A, Jaszai Mari Utca 3, 7623, Pecs
Lausmed Kft.
N/A, Fulep Lajos Utca 15, 6500, Baja
OMIII-Nyírő Gyula Kórház
Központi Intenzív és Aneszteziológiai Osztály, Lehel u. 59-61., 1135, Budapest
Komaromi Selye Janos Korhaz
Kardiológia 1 Szakrendelés, Szechenyi Utca 2, Szony, Komarom
Bacs-Kiskun Varmegyei Oktatokorhaz
I. Belgyógyászat- Kardiológiai Osztály, Nyiri Ut 38, 6000, Kecskemet
Bugat Pal Korhaz Kht.
Belgyógyászat, Dozsa Gyorgy Utca 20-22, 3200, Gyongyos
DRC Kft.
N/A, Ady Endre Utca 12/b, 8230, Balatonfured
Somogy Varmegyei Kaposi Mor Oktato Korhaz
Kardiológiai Osztály, Tallian Gyula Utca 20-32, 7400, Kaposvar
Belinus Bt.
N/A, Erzsebet Utca 11-13, 4025, Debrecen
Porcika Klinika
N/A, Nagy Sándor u. 11., 6800, Hódmezővásárhely
Semmelweis University
Városmajori Szív- és Érgyógyászati Klinika, Varosmajor Utca 68, Kerulet, Budapest XII
Belgyógyászati és Kardiológiai Magánrendelő
N/A, Alsó Körös sor 21., 5600, Békéscsaba
Borbanya Praxis Egeszsegugyi Kft.
N/A, Bazsalikom Utca 1/1, Borbanya, Nyiregyhaza
Soproni Erzsebet Oktato Korhaz Es Rehabilitacios Intezet
Kardiológiai Szakrendelés, Gyori Ut 15, 9400, Sopron
Central Hospital Of Northern Pest Military Hospital
Kardiológiai Osztály, Robert Karoly Korut 44, 1134, Budapest XIII
Vita Verum Medical Bt.
N/A, Fiskalis Ut 43, 8000, Szekesfehervar
Semmelweis University
Belgyógyászati és Hematológiai Klinika, Szentkiralyi Utca 46, VIII Kerulet, Budapest VIII
Belvaros-Lipotvaros Egeszsegugyi Szolgalat
Belgyógyászat-Kardiológia, Hercegprimas Utca 14-16, Kerulet, Budapest
Belvarosi Egeszseghaz Kft.
N/A, Ady Endre Utca 58, 8900, Zalaegerszeg
University Of Debrecen
Kardiológiai és Szívsebészeti Klinika, Moricz Zsigmond Korut 22, 4032, Debrecen
Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház-Rendelőintézet
Kardiológiai Osztály, Tószegi út 21., 5000, Szolnok
Uno Medical Trials Kft.
N/A, Vecsey Karoly Utca 39, 1152, Budapest XV
Obudai Egeszsegugyi Centrum Kft.
N/A, Zarda Utca 11-13, 8900, Zalaegerszeg

Italy

20 sites · Ongoing, recruitment ended
Humanitas Research Hospital
Cardiology Assistant, Via Alessandro Manzoni 56, 20089, Rozzano
ASST Grande Ospedale Metropolitano Niguarda
Assistan professor ASST Niguarda, Piazza Dell'ospedale Maggiore 3, 20162, Milan
Sapienza University Of Rome
Assistant Professor cardiovalurar sciences, Sapienza university of Roma, Viale Del Policlinico 155, 00161, Rome
Azienda Sanitaria Usl Toscana Sud Est
Department Azienda Sanitaria Usl Toscana Sud Est - ospedale san donato, Ospedale Area Aretina Nord, Via Pietro Nenni 20/22, Arezzo
Azienda Ospedaliera Papa Giovanni XXIII
Cardiovascular Department, Piazza Oms 1, 24127, Bergamo
Azienda Ospedaliera Universitaria Citta' Della Salute E Della Scienza Di Torino
Cardiologist at the University Hospital "Città della Salute), Corso Bramante 88, 10126, Turin
Alessandro Manzoni Hospital
Hospital consultant cardiologist, Via Dell' Eremo 9, 23900, Lecco
Azienda Ospedaliero Universitaria Di Sassari
medical director Ospedale Civile SS. Annunziata, Via Michele Coppino 26, 07100, Sassari
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
Cardiology - Rodolico Hospital, Via Santa Sofia 78, 95123, Catania
Fondazione IRCCS San Gerardo Dei Tintori
Cardiovascular Department Director, Via Giovanni Battista Pergolesi 33, 20900, Monza
Cliniche Gavazzeni S.p.A.
Interventional Cardiologist, Via Mauro Gavazzeni 21, 24125, Bergamo
Azienda Ospedaliero Universitaria Pisana
Department of surgical, Pisa university Hospital (Presidio di Cisanello), Via Roma 67, 56126, Pisa
Azienda Ospedaliera Sant Anna E San Sebastiano Di Caserta
UOC Cardiologia Clinica a Direzione Universitaria e UTIC, Via Ferdinando Palasciano Snc, 81100, Caserta
Fondazione Toscana Gabriele Monasterio
Head of Dept. of Diagnostic and Interventional Cardiology, Via Trieste 41, 56126, Pisa
University Hospital Of Ferrara
Electrophisiology laboratory, Cona, Via Aldo Moro 8, Ferrara
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Director of Department of Cardio-Thoracic-Vascular Diseases, Via Francesco Sforza 35, 20122, Milan
Azienda Ospedaliero Universitaria Di Modena
DIRECTOR OF THE CARDIOLOGY DIVISION OF THE POLYCLINIC OF MODENA, Largo Del Pozzo 71, 41124, Modena
Sandro Pertini Hospital
Cardiologist ASL RM2, Via Dei Monti Tiburtini 385, 00157, Rome
Fondazione IRCCS Policlinico San Matteo
Professor cardiovascular Diseases, Viale Camillo Golgi 19, 27100, Pavia
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department of cardiovascular Science, Largo Francesco Vito 1, 00168, Rome

Latvia

3 sites · Ongoing, recruitment ended
Pauls Stradins Clinical University Hospital
Latvian Centre of Cardiology, Pilsonu Iela 13, 1002, Riga
Daugavpils Regional Hospital SIA
Department of Cardiology, Vasarnicu Iela 20, 5417, Daugavpils
Rigas Austrumu kliniska universitates slimnica SIA
Clinic Gaiļezers, Hipokrata Iela 2, 1038, Riga

Lithuania

8 sites · Ongoing, recruitment ended
Inmedica UAB
NA, Savanoriu Pr. 169, Kauno M. Sav., Kovno
Klinikiniai Sprendimai UAB
NA, P. Luksio G. 3, Kauno M. Sav., Kovno
Vilnius University Hospital
Biomedical Research Department, Santariskiu G. 2, Vilniaus M. Sav., Vilnius
Lietuvos sveikatos mokslu universiteto Kauno ligonine
NA, Josvainiu G. 2, Kauno M. Sav., Kovno
Inlita UAB
NA, Santariskiu G. 5, Vilniaus M. Sav., Vilnius
Klaipeda University Hospital
Cardiology Clinic, Liepojos str. 45, LT-92288, Klaipeda
Saules seimos medicinos centras UAB
NA, Partizanu G. 27d, Kauno M. Sav., Kaunas
Vilnius University Hospital
Center of Cardiology and Angiology, Santariskiu G. 2, Vilniaus M. Sav., Vilnius

Netherlands

23 sites · Ongoing, recruitment ended
Stichting Radboud University Medical Center
Cardiology, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen
Jeroen Bosch Ziekenhuis
Cardiology, Henri Dunantstraat 1, 5223 GZ, 's-Hertogenbosch
Green Heart Hospital
Cardiology, Bleulandweg 10, 2803 HH, Gouda
Stichting Zuyderland Medisch Centrum
Cardiology, Henri Dunantstraat 5, 6419 PC, Heerlen
Stichting Meander Medisch Centrum
Cardiology, Maatweg 3, 3813 TZ, Amersfoort
Ikazia Ziekenhuis
Cardiology, Montessoriweg 1, 3083 AN, Rotterdam
St Antonius Hospital
Cardiology, Soestwetering 1, 3543 AZ, Utrecht
Deventer Ziekenhuis
Cardiology, Nico Bolkesteinlaan 75, 7416 SE, Deventer
Elkerliek Ziekenhuis
Cardiology, Wesselmanlaan 25, 5707 HA, Helmond
Elisabeth-TweeSteden Ziekenhuis
Cardiology, Dr. Deelenlaan 5, 5042 AD, Tilburg
Stichting Ziekenhuis Gelderse Vallei
Cardiology, Willy Brandtlaan 10, 6716 RP, Ede Gld
Gelre Hospitals
Cardiology, Albert Schweitzerlaan 31, 7334 DZ, Apeldoorn
Stichting Sint Franciscus Vlietland Groep
Cardiology, Kleiweg 500, 3045 PM, Rotterdam
Amsterdam UMC
Cardiology, Meibergdreef 9, 1105 AZ, Amsterdam
Stichting Catharina Ziekenhuis
Cardiology, Michelangelolaan 2, 5623 EJ, Eindhoven
Maxima Medisch Centrum
Cardiology, De Run 4600, 5504 DB, Veldhoven
D & A Research B.V.
Cardiology, Hegedyk 9, 8601 ZR, Sneek
Stichting Alrijne Zorggroep
Cardiology, Simon Smitweg 1, 2353 GA, Leiderdorp
Stichting Ziekenhuisgroep Twente
Cardiology, Zilvermeeuw 1, 7609 PP, Almelo
Stichting Noordwest Ziekenhuisgroep
Cardiology, Wilhelminalaan 12, 1815 JD, Alkmaar
Slingeland Ziekenhuis
Cardiology, Kruisbergseweg 25, 7009 BL, Doetinchem
Stichting OLVG
Cardiology, Oosterpark 9, 1091 AC, Amsterdam
Reinier De Graaf
Cardiology, Reinier De Graafweg 5, 2625 AD, Delft

Poland

56 sites · Ongoing, recruitment ended
Centrum Medyczne Med-Gastr Sp. z o.o.
n/a, Ul. Mokra 4, 91-034, Lodz
Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im. Prof. Dr Hab. Med. Eleonory Reicher
Centrum Wsparcia Badan Klinicznych, Ul. Spartanska 1, 02-637, Warsaw
Ilkowski I Partnerzy sp.p. Lekarzy
NZOZ NEURO-KARD Ilkowski i Partnerzy Spółka Partnerska Lekarzy, Ul. Wierzbowa 2/2, 61-853, Poznan
Wojewodzki Szpital Im. Sw.Ojca Pio W Przemyslu
Oddzial Kardiologii z Pododdz Intensywnego Nadzoru Kardiologicznego, Pododdz Kardiologii Inwazyjnej, Ul. Monte Cassino 18, 37-700, Peremyshl
Etg Warszawa Sp. z o.o.
ETG Warszawa, Ul. Wynalazek 4, 02-677, Warsaw
Pro Life Medica Sp. z o.o.
ETG Lublin, Ul. Wladyslawa Kunickiego 26a, 20-412, Lublin
Szpital Specjalistyczny Im. Ludwika Rydygiera W Krakowie Sp. z o.o.
Oddział Kardiologii i Chorob Wewnetrznych, Os. Zlotej Jesieni 1, 31-826, Cracow
Velocity Nova Sp. z o.o.
Velocity Zamość, Ul. Peowiakow 1, 22-400, Zamosc
Lukmed 2 Sp. z o.o.
ETG Siedlce, Ul. Mlynarska 16 B, 08-110, Siedlce
Niepubliczny Zaklad Opieki Zdrowotnej Twoje Zdrowie El Sp. z o.o.
n/a, ul. Elizy Orzeszkowej 13, 82-300, Elblag
4 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej We Wroclawiu
Osrodek Chorob Serca Klinika Kardiologii, Ul. Rudolfa Weigla 5, 53-114, Wroclaw
NZOZ Centrum Medyczne SERAFIN-MED Halina Serafin
N/A, ul. Hutnicza 1, 58-130, Żarów
Futuremeds Sp. z o.o.
FutureMeds Lodz, Ul. Gruszowa 2, 91-363, Lodz
Silmedic Sp. z o.o.
n/a, Ul. Gen. Wladyslawa Sikorskiego 30 Lok 70, 40-282, Katowice
In Vivo Sp. z o.o.
In-Vivo Bydgoszcz, Ul. Kaszubska 17h, 85-048, Bydgoszcz
NZOZ "ALL-MED" Centrum Medyczne Specjalistyczne Gabinety Lekarskie Marcin Ogorek
n/a, ul. Armii Krajowej 43A, 94-046, Lodz
Centrum Medyczne Ogrodowa G. I M. Kania Lekarze I Lekarze Dentysci sp.p.
Poradnia Kardiologiczna Lowicz, ul. Batalionow Chlopskich 2B, 99-400, Lowicz
Linden Sp. z o.o. sp.k.
n/a, Ul. Lipska 8, 30-721, Cracow
Centrum Medyczne Kermed Renata Bijata-Bronisz I Ewa Kowalinska Sp. j.
NZOZ Centrum Medyczne KERmed, Ul. Krolowej Jadwigi 16, 85-231, Bydgoszcz
Niepubliczny Zakład Opieki Zdrowotnej "TERAPIA OPTIMA"
N/A, ul. Medyków 18, 40-752, Katowice
Indywidualna Specjalistyczna Praktyka Lekarska Wlodzimierz Kus
n/a, ul. Zolnierska 76, 94-255, Lodz
Centrum Medyczne Pratia Bydgoszcz
n/a, Ul. Wojciecha Lochowskiego 7a, 85-796, Bydgoszcz
Sedimed Sp. z o.o.
CM Sedimed, Ul. Przyjazni 66/6, 53-030, Wroclaw
Ostrowieckie Centrum Medyczne Anna Olech Cudzik Krzysztof Cudzik s.c.
n/a, Ul. Ilzecka 31a, 27-400, Ostrowiec Swietokrzyski
M2m Med. Sp. z o.o. Sp. j.
N/A, Ul. Zabrska 17, 40-083, Katowice
Medicome Sp. z o.o.
n/a, Plac Tadeusza Kosciuszki 12, 32-600, Oswiecim
Med – Polonia Sp. z o.o.
n/a, Ul. Obornicka 262, 60-693, Poznan
Poradnia Kardiologiczna Jaroslaw Jurowiecki
n/a, Ul. Jaskowa Dolina 105, 80-286, Gdansk
Velocity Nova Sp. z o.o.
Velocity Lublin, Ul. Kazimierza Przerwy-Tetmajera 21, 20-362, Lublin
1 Nzoz Pro Cordis Sopockie Centrum Badan Kardiologicznych Pawel Miekus 2 Indywidualna Specjalistyczna Praktyka Lekarska Pawel Miekus
n/a, Ul. Partyzantow 39/64, 81-423, Gdynia
Futuremeds Sp. z o.o.
FutureMeds Warszawa Centrum, Ul. Sapiezynska 3, 00-215, Warsaw
Clinmedica Research Sp. z o.o.
Clinmedica Research, Ul. Ogrodowa 21/23, 96-100, Skierniewice
Santa Sp. z o.o.
Santa Familia Centrum Badan, Profilaktyki i Leczenia, Ul. Stanislawa Wigury 19, 90-368, Lodz
Specjalistyczna Praktyka Lekarska Ewa Mirek Bryniarska
n/a, Ul. Kazimierza Wielkiego 118, 30-082, Krakow
Kardio Brynow Sp z o.o.
n/a, Ul. Rolna 17/4-5, 40-555, Katowice
Futuremeds Sp. z o.o.
Centrum Medyczne AMED Warszawa Targowek, Ul. Sw. Wincentego 93/7, 03-291, Warsaw
Wojewodzki Szpital Specjalistyczny W Bialej Podlaskiej
Osrodek Innowacyjnych Terapii, Ul. Terebelska 57/65, 21-500, Biala Podlaska
Centrum Medyczne Zdrowa J. Trebacz W. Zajdel Sp. j.
Centrum Medyczne ZDROWA, Ul. Zdrowa 1 Lok. 11, 31-216, Cracow
1 Wojskowy Szpital Kliniczny Z Poliklinika samodzielny publiczny zakład opieki zdrowotnej W Lublinie
Oddzial Kardiologiczny, Ul. Aleje Raclawickie 23, 20-049, Lublin
Beata Miklaszewicz & Dariusz Dabrowski Cardiamed Sp. j.
n/a, Ul. Grunwaldzka 7, 59-220, Legnica
Centrum Medyczne Mbb-Med Marta Blach-Burek
n/a, Ul. Mieszka I 9c, 32-500, Chrzanow
Centrum Medyczne Pratia Katowice
n/a, Ul. Dabrowki 13, 40-081, Katowice
Centrum Medyczne Intercor Sp. z o.o.
n/a, Ul. Kasztanowa 57, 85-605, Bydgoszcz
Clinical Medical Research Sp. z o.o.
n/a, Aleja Wojciecha Korfantego 138, 40-156, Katowice
Diab Serwis Popenda Sp. j.
N/A, Jozefa Ryszki 51, 41-500, Chorzow
HEUREKA Hanna Szalecka
Niepubliczny Zaklad Opieki Zdrowotnej HEUREKA, Ul. Ludowa 5, 05-500, Piaseczno
Mcbk s.c. Iwona Czajkowska Anna Podrazka Szczepaniak
MCBK, Ul. Daleka 32, 05-825, Grodzisk Mazowiecki
Pratia Jelenia Gora
n/a, Ul. Wiejska 11, 58-506, Jelenia Gora
Poradnia Aka-Med Centrum Sp. z o.o
NA, ul. 1 Maja 323, 41-710, Ruda Śląska
Indywidualna Specjalistyczna Praktyka Lekarska W Dziedzinie Kardiologii Lek.Med. Krzysztof Cymerman
n/a, Ul. Mjr. Henryka Sucharskiego 2, 81-157, Gdynia
Centrum Medyczne Medyk Sp. z o.o.
Centrum Medyczne „Medyk", Ul. Fryderyka Szopena 1, 35-055, Rzeszow
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu
Instytut Chorob Serca, Ul. Borowska 213, 50-556, Wroclaw
Krakowskie Centrum Medyczne Sp. z o.o.
n/a, Ul. Mikolaja Kopernika 32 St, 31-501, Cracow
Pratia S.A.
N/A, Ul. Bytowska 70, 89-600, Chojnice
Futuremeds Sp. z o.o.
FutureMeds Olsztyn, Ul. Bohaterow Monte Cassino 4, 10-165, Olsztyn
Pro Life Medica Sp. z o.o.
ETG Zamosc, Ul. Gesia 3, 22-400, Zamosc

Portugal

8 sites · Ongoing, recruitment ended
Unidade Local De Saude De Lisboa Ocidental E.P.E.
Cardiology, Av Prof Dr Reinaldo Dos Santos, 2790-134, Carnaxide
UCardio
Cardiology, Largo da Igreja Velha, Edifício CCA, Torres Novas
Unidade Local De Saude De Coimbra E.P.E.
Cardiology, Praceta Professor Mota Pinto, 3004-561, Coimbra
Unidade Local De Saude De Santa Maria E.P.E.
Cardiology, Avenida Professor Egas Moniz, 1649-035, Lisbon
Centro Hospitalar Universitario Cova Da Beira E.P.E.
Cardiology, Bairro Do Alvito, 6200-251, Covilha
Unidade Local De Saude Do Baixo Mondego
Cardiology, Gala S Pedro, 3094-001, Figueira Da Foz
Unidade Local De Saude De Entre O Douro E Vouga E.P.E.
Cardiology, Rua Doutor Candido Pinho, 4520-211, Santa Maria Da Feira
Unidade Local De Saude De Gaia/Espinho E.P.E.
Cardiology, Rua Conceicao Fernandes S/n, 4434-502, Vila Nova De Gaia

Romania

17 sites · Ongoing, recruitment ended
Institutul de Boli Cardiovasculare Prof. Dr. George I.M. Georgescu
Cardiologie, Bulevardul Carol I Nr 50, 700503, Iasi
Centrul Medical Unirea S.R.L.
Cardiologie, Strada Maniu Iuliu Nr 49, 500091, Brasov
Spitalul Judetean De Urgenta Braila
Cardiologie, Soseaua Buzaului 2, 810325, Braila
Sal Med S.R.L.
Cardiologie, Block P7 Scara E Etaj P, Strada Traian, Pitesti
U 2 Serv Com S.R.L.
Cardiologie, Bl I1 Sc D, Strada Alexandru Cel Bun Nr 6, Suceava
Spitalul Clinic Judetean De Urgenta Bihor
Cardiologie, Str Gheorghe Doja Nr 65, 410169, Oradea
Medicali's S.R.L.
Cardiologie, Strada Cernauti 13, 300362, Timisoara
Institutul De Urgenta Pentru Boli Cardiovasculare Prof. Dr. C. C. Iliescu
Cardiologie, Soseaua Fundeni 258, 022328, Bucharest
Clinica Medicala Data Plus S.R.L.
Medicina Interna, Strada Prof. Grigore Cobalcescu 35, 010192, Bucharest
Cmi Dr. Podoleanu Cristian
Cardiologie, Aleea Cornisa Nr 5, Ap. 4, Targu Mures
Centrul Medical De Diagnostic Si Tratament Ambulator Neomed S.R.L.
Cardiologie, Strada Crisului Nr. 1, 500283, Brasov
Spitalul Clinic Judetean De Urgenta Sibiu
Medicina Interna, Bulevardul Coposu Corneliu 2-4, 550245, Sibiu
Angiocare S.R.L.
Cardiologie, Strada Republicii Nr 8, 400015, Cluj-Napoca
Delta Health Care S.R.L.
Cardiologie, Str Nicolae Caramfil Nr 85a Sector 1, 014146, Bucharest
Cardiomed S.R.L.
Cardiologie, Aleea Neculai Tudor C1, 700732, Jassi
Cabinet Medical Individual de Cardiologie Dr. Pop Calin
Cardiologie, Strada George Cosbuc Nr 25A, ap2, Baia Mare
Spitalul Clinic Judetean De Urgenta Targu Mures
Sectia Clinica Cardiologie, Strada Marinescu Gheorghe 50, 540136, Targu Mures

Slovakia

19 sites · Ongoing, recruitment ended
Cardio D&R s.r.o. Kosice
Cardiological ambulance, Marsala Koneva 1, Dargovskych Hrdinov, Kosice
Interna SK s.r.o.
Cardiology and internal medicine clinic, Mudr. Pribulu 412/4, 089 01, Svidnik
Thyreomedical s.r.o.
Endocrinology and Internal Clinic_Site correct address is Tacevska 3998, 08501 Bardejov, Beloveza 154, 086 14, Beloveza
Kardio 1 s.r.o.
Cardiological ambulance_Correct adrress is Namestie republiky 15, 98401 Lucenec, Pavla Dobsinskeho 13, 984 03, Lucenec
Medispol s.r.o.
Internal and Cardiological Ambulance, Konstantinova 17, 080 01, Presov
Veria s.r.o.
Cardiological ambulance, Svabinskeho 17, 851 01, Petrzalka
Alian s.r.o.
Angiological ambulance, Sv. Jakuba 33, 085 01, Bardejov
Kardiovaskularne centrum s.r.o.
Cardiovascular center, Dumbierska 32, 831 01, Nove Mesto
Nemocnica S Poliklinikou Brezno N.O.
Cardiological ambulance, 273, Banisko 1, Brezno
Vychodoslovensky Ustav Srdcovych A Cievnych Chorob a.s.
I. Cardiology clinic - arrhythmology department, Ondavska 8, Zapad, Kosice - Zapad
Medical group Kosice s.r.o.
Cardiological and Internal ambulance, Mudronova 29, Juh, Kosice
Medivasa s.r.o.
Angiological ambulance, Vojtecha Spanyola 8187, 010 01, Zilina
Národny ustav srdcovych a cievnych chorob a.s.
Cardiology Clinic - Arrhythmology Department, Pod Krasnou Horkou 1, Nove Mesto, Bratislava
Fakultna Nemocnica Nitra
Internal Clinic_Correct Postal Code is 95001, Spitalska 6, Stare Mesto, Nitra
Medi M&M s.r.o.
Internal Ambulance, Ceskoslovenskej Armady 35, 045 01, Moldava Nad Bodvou
Cardioinvest s.r.o.
Internal Medicine Clinic_Correct adrress stated on Insurance Cert. is Flengera 10,94002 Nove Zamky, Moyzesova 1078/25, 940 02, Nove Zamky
Cardioconsult s.r.o.
Cardiological ambulance, Cajkovskeho 5, 811 04, Stare Mesto
Kardiomed s.r.o.
Outpatient Dept of Cardiology and Internal medicine, Mieru 1390, 984 01, Lucenec
Fakultna Nemocnica S Poliklinikou J. A. Reimana Presov
Cardiocenter, Jana Holleho 5898/14, 080 01, Presov

Spain

16 sites · Ongoing, recruitment ended
Hospital De Manises
Cardiology, Avinguda De La Generalitat Valenciana 50, 46940, Manises
Hospital Universitario De La Princesa
Cardiology, Calle De Diego De Leon 62, 28006, Madrid
Hospital Universitario La Paz
Cardiology, Paseo Castellana 261, 28046, Madrid
Hospital De La Santa Creu I Sant Pau
Cardiology, Calle De San Antonio Maria Claret 167, 08025, Barcelona
University Clinical Hospital Virgen De La Arrixaca
Cardiology, Carretera De Cartagena S/n, El Palmar, Murcia
Complexo Hospitalario Universitario De Santiago
Cardiology, Calle Choupana Da S/n, 15706, Santiago De Compostela
Hospital Clinico Universitario De Valencia
Cardiology, Avenida Blasco Ibanez 17, 46010, Valencia
Complexo Hospitalario Universitario A Coruna
Cardiology, Lugar Jubias De Arriba 84, 15006, A Coruna
Hospital Universitario Virgen De La Victoria
Cardiology, Calle Del Arroyo Teatinos S N, 29010, Malaga
Hospital La Luz Grupo Quironsalud
Cardiology, Calle Del Maestro Angel Llorca 8, 28003, Madrid
Bellvitge University Hospital
Cardiology, Carretera De La Feixa Llarga S/n, Poligono Industrial De La Zona Ranca De Barcelona, L'hospitalet De Llobregat
Parc Tauli Hospital Universitari
Cardiology, Parc Del Tauli 1 Edifici Santa Fe Ala Izquierda Planta 2ª, 08208, Sabadell
Hospital Del Mar
Cardiology, Passeig Maritim De La Barceloneta 25-29, 08003, Barcelona
Hospital General Universitario De Valencia
Cardiology, Avenida Del Tres Cruces S/n, 46014, Valencia
Hospital General Universitario De Alicante
Cardiology, Avinguda Del Pintor Baeza 12, 03010, Alicante
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida
Cardiology, Avinguda De L'alcalde Rovira Roure 80, 25196, Lleida

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Belgium 2023-09-27 2023-09-27 2025-01-17
Bulgaria 2023-08-23 2023-08-23 2025-01-17
Croatia 2024-01-30 2024-01-30 2025-01-17
Czechia 2023-09-05 2023-09-05 2025-01-17
Denmark 2023-10-09 2023-10-09 2025-01-17
Estonia 2023-10-10 2023-10-10 2025-01-17
France 2023-10-12 2023-10-12 2025-01-17
Germany 2023-09-06 2023-09-06 2025-01-17
Greece 2024-06-17 2024-06-17 2025-01-17
Hungary 2023-08-31 2023-08-31 2025-01-17
Italy 2023-10-04 2023-10-04 2025-01-17
Latvia 2024-05-02 2024-05-02 2025-01-17
Lithuania 2023-09-04 2023-09-04 2025-01-17
Netherlands 2023-09-07 2023-09-20 2025-01-17
Poland 2023-09-13 2023-09-13 2025-01-17
Portugal 2023-09-29 2023-09-29 2025-01-17
Romania 2023-09-07 2023-09-07 2025-01-17
Slovakia 2023-09-07 2023-09-07 2025-01-17
Spain 2023-11-22 2023-11-22 2025-01-17

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Serious breaches 1 · Art. 52 CTR

Serious breach SB-48327

Sponsor became aware
2024-09-19
Date of breach
2024-09-11
Submission date
2025-06-24
Member states concerned
Belgium, Bulgaria, Croatia, Czechia, Denmark, Estonia, France, Germany, Greece, Hungary, Italy, Latvia, Lithuania, Portugal, Romania, Spain, Netherlands, Poland, Slovakia
Categories
Protocol
Areas impacted
Subject safety
Benefit-risk balance changed
No
Description
As per the protocol of Study 70033093AFL3002 (LIBREXIA AF) in participants with atrial fibrillation (AF) or flutter, participants receiving an anticoagulant indicated for AF before study entry should be instructed to discontinue previous anticoagulation therapy before starting the study treatment of blinded milvexian or apixaban, due to the potential of increased risk of bleeding. As per Protocol, participants who received a direct oral anticoagulant (DOAC) or a vitamin K antagonist before study entry should be instructed to discontinue previous anticoagulation therapy. Additional chronic anticoagulants (e.g. VKA, Factor IIa or FXa inhibitors) are prohibited concomitant therapies.
The initial incidence of a participant receiving double coagulation therapy was discovered during a routine site monitoring visit (SMV) at a site in Germany in Sep 2024. While reporting this incident as a major protocol deviation, it was noted that there was a similar protocol deviation for another participant at the same site in April 2024. A quality investigation was initiated and a total of 4 incidents, 2 participants at the above-mentioned site in Germany, and 1 participant each at a site in Denmark and a site in Japan were identified as having taken the prohibited double coagulation therapy for AF for at least 5 days and outside of a medically supervised setting. These 4 incidents were included in the initial report. Based on review of all identified incidents, there were no reports of any bleeding events, or adverse events during the time of double anticoagulant administration.
All impacted sites were immediately notified and planned retraining at the time the protocol deviations were discovered. Sponsor has continued ongoing surveillance and implemented appropriate mitigations as needed.
Sponsor actions
All sites with identified incidents were immediately notified and the Sponsor planned re-training when the issue was discovered. All of the identified incidents have been recorded as Major Protocol Deviations.
To prevent additional incidents, Sponsor sent out reminders, developed a mandatory training module for all participating sites, and made an enhancement to the Interactive Web Response System (IWRS) to increase awareness of this potential error.
Sponsor will continue surveillance of concomitant anticoagulants throughout the duration of the trial.
OrganisationCityCountryType
Vivantes Netzwerk fuer Gesundheit GmbH Berlin Germany Clinical investigator

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 489 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) D1_Protocol_EL_2022-501419-15-00_Redacted Am 3
Protocol (for publication) D1_Protocol_EN_2022-501419-15-00_Redacted Am 3
Protocol (for publication) D4_Patient Facing Document_EQ-5D-5L_ePRO_Layout 1.00
Protocol (for publication) D4_Patient Facing Document_EQ-5D-5L_ePRO_Layout_LV 1.0
Protocol (for publication) D4_Patient Facing Document_EQ-5D-5LIA_ePRO_Layout_LV 1.0
Protocol (for publication) D4_Patient Facing Document_EQ-5D-5LIT_ePRO_Layout 1.00
Protocol (for publication) D4_Patient Facing Document_PROMIS29_ePRO_Layout 1.00
Protocol (for publication) D4_Patient Facing Document_PROMIS29_ePRO_Layout_LV 1.0
Protocol (for publication) D4_PRO_EQ-5D-5L_BEFR_Digital Interviewer_2022-501419-15-00 1.0
Protocol (for publication) D4_PRO_EQ-5D-5L_BEFR_Patient_2022-501419-15-00 1.0
Protocol (for publication) D4_PRO_EQ-5D-5L_BENL_Digital Interviewer_2022-501419-15-00 1.0
Protocol (for publication) D4_PRO_EQ-5D-5L_BENL_Patient_2022-501419-15-00 1.0
Protocol (for publication) D4_PRO_EQ-5D-5L_DE_Digital Interviewer_2022-501419-15-00 1.0
Protocol (for publication) D4_PRO_EQ-5D-5L_DE_Patient_2022-501419-15-00 1.0
Protocol (for publication) D4_PRO_EQ-5D-5L_EL_Patient_2022-501419-15-00 1.00
Protocol (for publication) D4_PRO_EQ-5D-5L_EL_Telephone Interviewer_2022-501419-15-00 1.00
Protocol (for publication) D4_PRO_EQ-5D-5L_ES_Digital Interview_2022-501419-15-00 1.0
Protocol (for publication) D4_PRO_EQ-5D-5L_ES_Patient_2022-501419-15-00 1.0
Protocol (for publication) D4_PRO_EQ-5D-5L_FR_Digital Interviewer_2022-501419-15-00 1.0
Protocol (for publication) D4_PRO_EQ-5D-5L_FR_Patient_2022-501419-15-00 1.0
Protocol (for publication) D4_PRO_EQ-5D-5L_HR_Digital Interviewer_2022-501419-15-00 0.01
Protocol (for publication) D4_PRO_EQ-5D-5L_HR_Patient_2022-501419-15-00 0.01
Protocol (for publication) D4_PRO_EQ-5D-5L_HU_Digital Interviewer_2022-501419-15-00 1.00
Protocol (for publication) D4_PRO_EQ-5D-5L_HU_Patient_2022-501419-15-00 1.00
Protocol (for publication) D4_PRO_EQ-5D-5L_IT_Digital Interviewer_2022-501419-15-00 1.0
Protocol (for publication) D4_PRO_EQ-5D-5L_IT_Patient_2022-501419-15-00 1.0
Protocol (for publication) D4_PRO_EQ-5D-5L_LT_Digital Interview_2022-501419-15-00 1.00
Protocol (for publication) D4_PRO_EQ-5D-5L_LT_Patient_2022-501419-15-00 1.00
Protocol (for publication) D4_PRO_EQ-5D-5L_LTRUS_Patient_2022-501419-15-00 1.00
Protocol (for publication) D4_PRO_EQ-5D-5L_LTRUS_Telephone Interview_2022-501419-15-00 1.00
Protocol (for publication) D4_PRO_EQ-5D-5L_PT_Digital Interviewer_2022-501419-15-00 1.00
Protocol (for publication) D4_PRO_EQ-5D-5L_PT_Patient_2022-501419-15-00 1.00
Protocol (for publication) D4_PRO_EQ-5D-5L_RO_Patient_2022-501419-15-00 1.00
Protocol (for publication) D4_PRO_EQ-5D-5L_RO_Telephone Interviewer_2022-501419-15-00 1.00
Protocol (for publication) D4_PRO_PROMIS-29_BEFR_2022-501419-15-00 2.1
Protocol (for publication) D4_PRO_PROMIS-29_BENL_2022-501419-15-00 2.1
Protocol (for publication) D4_PRO_PROMIS-29_DE_2022-501419-15-00 2.1
Protocol (for publication) D4_PRO_PROMIS-29_EL_2022-501419-15-00 1.00
Protocol (for publication) D4_PRO_PROMIS-29_ES_2022-501419-15-00 2.1
Protocol (for publication) D4_PRO_PROMIS-29_FR_2022-501419-15-00 2.1
Protocol (for publication) D4_PRO_PROMIS-29_HR_2022-501419-15-00 0.01
Protocol (for publication) D4_PRO_PROMIS-29_HU_2022-501419-15-00 1.00
Protocol (for publication) D4_PRO_PROMIS-29_IT_2022-501419-15-00 2.1
Protocol (for publication) D4_PRO_PROMIS-29_LT_2022-501419-15-00 1.00
Protocol (for publication) D4_PRO_PROMIS-29_LTRUS_2022-501419-15-00 1.00
Protocol (for publication) D4_PRO_PROMIS-29_PT_2022-501419-15-00 1.00
Protocol (for publication) D4_PRO_PROMIS-29_RO_2022-501419-15-00 1.00
Recruitment arrangements (for publication) K0_Cover letter SM-1_san N/A
Recruitment arrangements (for publication) K0_Cover letter_Bulgaria_Non-SM-1_san N/A
Recruitment arrangements (for publication) K0_Cover letter_Bulgaria_RA_Part II_san N/A
Recruitment arrangements (for publication) K0_Cover Letter_Bulgaria_SM-3_san N/A
Recruitment arrangements (for publication) K0_Cover Letter_Bulgaria_SM-4_san N/A
Recruitment arrangements (for publication) K0_Cover Letter_Bulgaria_SM-5 N/A
Recruitment arrangements (for publication) K1_ Recruitment arrangements_Pre-Consent Study Overview Animation Storyboard- san_red V01SVK-sk
Recruitment arrangements (for publication) K1_2022-501419-15_Recruitment Arrangements_FRA_San 2
Recruitment arrangements (for publication) K1_70033093AFL3002_Netherlands_Template recruitment procedure_NLD_san N/A
Recruitment arrangements (for publication) K1_70033093AFL3002_Recruitment arrangements_Spain 3
Recruitment arrangements (for publication) K1_Patient Brochure_Redacted 01
Recruitment arrangements (for publication) K1_Patient Brochure_TC_redacted_san 01
Recruitment arrangements (for publication) K1_Pre-Consent Study Overview Animation Storyboard_redacted 01
Recruitment arrangements (for publication) K1_Recruitment and ICF Procedure_cs_san 2
Recruitment arrangements (for publication) K1_Recruitment arrangements 3.0
Recruitment arrangements (for publication) K1_Recruitment arrangements Informed consent procedure_san 1.0
Recruitment arrangements (for publication) K1_Recruitment arrangements_BEL_san V3.1
Recruitment arrangements (for publication) K1_Recruitment arrangements_BG_san 3.0
Recruitment arrangements (for publication) K1_Recruitment arrangements_Croatia_san 3.0
Recruitment arrangements (for publication) K1_Recruitment arrangements_EN_san 3.0
Recruitment arrangements (for publication) K1_Recruitment arrangements_Greece_San 3.0
Recruitment arrangements (for publication) K1_Recruitment arrangements_PL_san 3.0
Recruitment arrangements (for publication) K1_Recruitment arrangements_Recruitment procedure_san v3.0
Recruitment arrangements (for publication) K1_Recruitment arrangements_san V4.0
Recruitment arrangements (for publication) K1_Recruitment arrangements_san 3.0
Recruitment arrangements (for publication) K1_Recruitment arrangements_san 3.0
Recruitment arrangements (for publication) K1_Recruitment arrangements_san V3-0
Recruitment arrangements (for publication) K1_Recruitment arrangements_san N/A
Recruitment arrangements (for publication) K1_Recruitment arrangements_san V4.0
Recruitment arrangements (for publication) K1_Recruitment arrangements_san V3.0
Recruitment arrangements (for publication) K2_2022-501419-15_Recruitment Material_Banner Ads_FRA_not dated_San NA
Recruitment arrangements (for publication) K2_2022-501419-15_Recruitment Material_Patient Brochure_FRA_Red_San V01FRAfr
Recruitment arrangements (for publication) K2_2022-501419-15_Recruitment Material_Pre-Consent Storyboard_FRA_Red_San V01FRA(fr)
Recruitment arrangements (for publication) K2_2022-501419-15_Recruitment Material_Social Media and Clinical Trial Posts_FRA_San V01FRA(fr)
Recruitment arrangements (for publication) K2_70033093AFL3002_banner Ads_san NA
Recruitment arrangements (for publication) K2_70033093AFL3002_DTP_Appointment Cancellation Request Call Script_NLD V01NLD(nl)
Recruitment arrangements (for publication) K2_70033093AFL3002_DTP_Appointment Request with Warm Transfer Call Script_NLD V01NLD(nl)
Recruitment arrangements (for publication) K2_70033093AFL3002_DTP_Direct Mail Letter_NLD V01NLD(nl)
Recruitment arrangements (for publication) K2_70033093AFL3002_DTP_Email_NLD V01NLD(nl)
Recruitment arrangements (for publication) K2_70033093AFL3002_DTP_ePR Participant Journey Emails_NLD V01NLD(nl)
Recruitment arrangements (for publication) K2_70033093AFL3002_DTP_Inbound Call Script_NLD V01NLD(nl)
Recruitment arrangements (for publication) K2_70033093AFL3002_DTP_Marketing and Outreach Content_NLD V01NLD(nl)
Recruitment arrangements (for publication) K2_70033093AFL3002_DTP_Outbound Call Script_NLD V01NLD(nl)
Recruitment arrangements (for publication) K2_70033093AFL3002_DTP_Patient Pre-screening Website Content_NLD V01NLD(nl)
Recruitment arrangements (for publication) K2_70033093AFL3002_DTP_Print Ads Large_NLD V01NLD(nl)
Recruitment arrangements (for publication) K2_70033093AFL3002_DTP_Print Ads Small_NLD V01NLD(nl)
Recruitment arrangements (for publication) K2_70033093AFL3002_DTP_Radio Script_NLD V01NLD(nl)
Recruitment arrangements (for publication) K2_70033093AFL3002_DTP_Schedule Appointment Call Script Inbound_NLD V01NLD(nl)
Recruitment arrangements (for publication) K2_70033093AFL3002_DTP_Schedule Appointment Call Script Outbound_NLD V01NLD(nl)
Recruitment arrangements (for publication) K2_70033093AFL3002_DTP_Study Closed Inbound Call Script_NLD V01NLD(nl)
Recruitment arrangements (for publication) K2_70033093AFL3002_DTP_TV Script_NLD V01NLD(nl)
Recruitment arrangements (for publication) K2_70033093AFL3002_DTP_Warm Transfer New Site Call Script_NLD V01NLD(nl)
Recruitment arrangements (for publication) K2_70033093AFL3002_Pre-Consent Study Overview Animation Storyboard_red-san V01NLD
Recruitment arrangements (for publication) K2_70033093AFL3002_Recruitment Material_Banner Ads_san 1
Recruitment arrangements (for publication) K2_70033093AFL3002_Recruitment material_Brochure_red-san V01NLD01
Recruitment arrangements (for publication) K2_70033093AFL3002_Recruitment Material_Patient Brochure_Red 1
Recruitment arrangements (for publication) K2_70033093AFL3002_Recruitment Material_Social Media Clinical Trial Posts_14Jul2023_san 1
Recruitment arrangements (for publication) K2_70033093AFL3002_Recruitment Material_Study Overview Animation Storyboard_Red_san 1
Recruitment arrangements (for publication) K2_70033093AFL3002_Social Media and Clinical Trial Posts_san V01
Recruitment arrangements (for publication) K2_Librexia AF_Banner Ads 1
Recruitment arrangements (for publication) K2_Librexia AF_Banner Ads_San 1.0
Recruitment arrangements (for publication) K2_Librexia AF_Pre-Consent Study Overview Animation Storyboard_red_san 1
Recruitment arrangements (for publication) K2_Librexia AF_Pre-Consent Study Overview Animation Storyboard_redacted 1.0
Recruitment arrangements (for publication) K2_LIBREXIA AF_Social Media Clinical Trial Posts 1
Recruitment arrangements (for publication) K2_Other subject information material_Patient Brochure_red and san V1.0
Recruitment arrangements (for publication) K2_Patient Brochure_V01 GR_Redacted 1
Recruitment arrangements (for publication) K2_RecruitMat_Closed Inbound Call Script_san V01DEU(de)
Recruitment arrangements (for publication) K2_RecruitMat_Direct Mail Letter_san V01DEUde01
Recruitment arrangements (for publication) K2_RecruitMat_DTP Email_san V01DEU(de)
Recruitment arrangements (for publication) K2_RecruitMat_DTP Radio Script_san V01DEU(de)
Recruitment arrangements (for publication) K2_RecruitMat_DTP TV Script_san V01DEU(de)
Recruitment arrangements (for publication) K2_RecruitMat_Inbound Call Script_san V01DEU(de)
Recruitment arrangements (for publication) K2_RecruitMat_Large Newspaper Ad_san V01DEU(de)
Recruitment arrangements (for publication) K2_RecruitMat_Outbound Call Script_san V01DEU(de)
Recruitment arrangements (for publication) K2_RecruitMat_Outreach and Advertising_san V01DEU(de)
Recruitment arrangements (for publication) K2_RecruitMat_Participant Journey Emails_san V01DEU(de)
Recruitment arrangements (for publication) K2_RecruitMat_Patient Brochure_red-san 01 DEU(de)
Recruitment arrangements (for publication) K2_RecruitMat_Patient Pre-screening Website_san V01DEUde01
Recruitment arrangements (for publication) K2_RecruitMat_Schedule Appointment Inbound Call_san V01DEU(de)
Recruitment arrangements (for publication) K2_RecruitMat_Schedule Appointment Outbound Call_san V01DEU(de)
Recruitment arrangements (for publication) K2_RecruitMat_Small Newspaper Ad_san V01DEU(de)
Recruitment arrangements (for publication) K2_RecruitMat_Study Appointment Cancellation_san V01DEU(de)
Recruitment arrangements (for publication) K2_RecruitMat_Study Appointment Request Warm_san V01DEU(de)
Recruitment arrangements (for publication) K2_RecruitMat_Warm Transfer New Site Call Script_san V01DEU(de)
Recruitment arrangements (for publication) K2_Recruitment arrangements_upd_San 2.0
Recruitment arrangements (for publication) K2_Recruitment mat_Animation_red-san V01DEU(de)
Recruitment arrangements (for publication) K2_Recruitment mat_Banner Ads_san 1
Recruitment arrangements (for publication) K2_Recruitment mat_Social Media_san V01DEU(de)
Recruitment arrangements (for publication) K2_Recruitment Material Banner Ads_san N/A
Recruitment arrangements (for publication) K2_Recruitment Material Patient Animation Storyboard_san_redacted V01
Recruitment arrangements (for publication) K2_Recruitment Material Patient Brochure _san_Redacted V01 DNK01
Recruitment arrangements (for publication) K2_Recruitment Material Social Media Posts_san 01
Recruitment arrangements (for publication) K2_Recruitment material_Appointment Cancellation Request Call Script_PL_san V01POL(pl)
Recruitment arrangements (for publication) K2_Recruitment material_Appointment Request with Warm Transfer Call Script_PL_san V01POL(pl)
Recruitment arrangements (for publication) K2_Recruitment Material_Banner Ads_EN 01
Recruitment arrangements (for publication) K2_Recruitment material_Banner Ads_EST_et_01 EST(et)02
Recruitment arrangements (for publication) K2_Recruitment material_Banner Ads_EST_ru_01 EST(ru)02
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Recruitment arrangements (for publication) K2_Recruitment Material_Banner Ads_RO 01
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Subject information and informed consent form (for publication) L1_1_1_SIS and ICF Main Master_red-san 5.0
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Subject information and informed consent form (for publication) L2_2_Other subject information_Patient Study Guide_BGR_red-san 04 BGR(bg)
Subject information and informed consent form (for publication) L2_2022-501419-15_Important Patient Notice_FRA_san V01FRAfr
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Synopsis of the protocol (for publication) D1_Protocol synopsis_ES_2022-501419-15-00 Am 3
Synopsis of the protocol (for publication) D1_Protocol synopsis_FR_2022-501419-15-00 Am 3
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Synopsis of the protocol (for publication) D1_Protocol synopsis_IT_2022-501419-15-00 Am 3
Synopsis of the protocol (for publication) D1_Protocol synopsis_LT_2022-501419-15-00 Am 3
Synopsis of the protocol (for publication) D1_Protocol synopsis_NL_2022-501419-15-00 Am 3
Synopsis of the protocol (for publication) D1_Protocol synopsis_PL_2022-501419-15-00 Am 3
Synopsis of the protocol (for publication) D1_Protocol synopsis_PT_2022-501419-15-00 Am 3
Synopsis of the protocol (for publication) D1_Protocol synopsis_RO_2022-501419-15-00 Am 3
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Application history

34 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2023-04-11 Belgium Acceptable
2023-08-07
 2023-08-07
2 NON SUBSTANTIAL MODIFICATION NSM-1 2023-08-15 Acceptable
2023-08-07
 2023-08-15
3 NON SUBSTANTIAL MODIFICATION NSM-2 2023-08-15 Acceptable
2023-08-07
 2023-08-15
4 NON SUBSTANTIAL MODIFICATION NSM-3 2023-08-16 Acceptable
2023-08-07
 2023-08-16
5 NON SUBSTANTIAL MODIFICATION NSM-4 2023-08-16 Acceptable
2023-08-07
 2023-08-16
6 SUBSTANTIAL MODIFICATION SM-1 2023-09-14 Belgium Acceptable
2023-11-20
 2023-11-21
7 NON SUBSTANTIAL MODIFICATION NSM-6 2023-12-19 Acceptable
2023-11-20
 2023-12-19
8 SUBSTANTIAL MODIFICATION SM-2 2024-01-09 Acceptable 2024-02-07
9 NON SUBSTANTIAL MODIFICATION NSM-7 2024-02-13 2024-02-13
10 NON SUBSTANTIAL MODIFICATION NSM-8 2024-02-14 2024-02-14
11 NON SUBSTANTIAL MODIFICATION NSM-9 2024-02-16 Belgium 2024-02-16
12 NON SUBSTANTIAL MODIFICATION NSM-10 2024-02-23 2024-02-23
13 NON SUBSTANTIAL MODIFICATION NSM-11 2024-02-27 2024-02-27
14 SUBSTANTIAL MODIFICATION SM-3 2024-03-15 Belgium Acceptable
2024-06-03
 2024-06-03
15 NON SUBSTANTIAL MODIFICATION NSM-12 2024-06-19 2024-06-19
16 NON SUBSTANTIAL MODIFICATION NSM-13 2024-07-19 2024-07-19
17 NON SUBSTANTIAL MODIFICATION NSM-14 2024-08-28 2024-08-28
18 NON SUBSTANTIAL MODIFICATION NSM-15 2024-09-16 2024-09-16
19 NON SUBSTANTIAL MODIFICATION NSM-16 2024-09-17 2024-09-17
20 NON SUBSTANTIAL MODIFICATION NSM-17 2024-09-19 2024-09-19
21 NON SUBSTANTIAL MODIFICATION NSM-18 2024-09-24 2024-09-24
22 SUBSTANTIAL MODIFICATION SM-4 2024-10-11 Belgium Acceptable
2025-01-24
 2025-01-24
23 SUBSTANTIAL MODIFICATION SM-5 2025-04-24 Belgium Acceptable
2025-07-22
 2025-07-28
24 SUBSTANTIAL MODIFICATION SM-6 2025-09-01 Acceptable 2025-10-16
25 SUBSTANTIAL MODIFICATION SM-8 2025-09-02 Acceptable 2025-10-14
26 SUBSTANTIAL MODIFICATION SM-7 2025-09-03 Acceptable 2025-09-16
27 SUBSTANTIAL MODIFICATION SM-9 2025-09-17 Acceptable 2025-10-14
28 SUBSTANTIAL MODIFICATION SM-10 2025-09-25 Acceptable 2025-10-21
29 SUBSTANTIAL MODIFICATION SM-11 2025-10-02 Acceptable 2025-10-29
30 SUBSTANTIAL MODIFICATION SM-12 2025-12-02 Acceptable 2026-03-02
31 SUBSTANTIAL MODIFICATION SM-13 2025-12-09 Acceptable 2026-02-06
32 SUBSTANTIAL MODIFICATION SM-14 2025-12-22 Acceptable 2026-02-04
33 SUBSTANTIAL MODIFICATION SM-15 2026-01-30 Acceptable 2026-03-11
34 SUBSTANTIAL MODIFICATION SM-16 2026-03-16 Belgium Acceptable
2026-05-08
 2026-05-08

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