Dual antiplatelet therapy with ticagrelor and acetylsalicylic acid (ASA) vs. ASA only after isolated coronary artery bypass grafting in patients with acute coronary syndrome (TACSI trial)

2023-508551-40-00 Protocol TACSI-01 Therapeutic use (Phase IV) Ongoing, recruitment ended

Start 8 Jun 2018 · Status Ongoing, recruitment ended · 5 EU/EEA countries · 22 sites · Protocol TACSI-01

Overview

Sponsor-declared trial summary

Phase Therapeutic use (Phase IV)
Status Ongoing, recruitment ended
Participants planned 2,200
Countries 5
Sites 22

Coronary artery multi-vessel disease and left main stenosis

To assess whether dual antiplatelet therapy (DAPT) with ticagrelor and ASA compared to ASA alone improves 12 months outcome defined as major adverse cardiovascular events (MACE) after isolated Coronary Artery Bypass Grafting (CABG) in Acute Coronary Syndrome (ACS) patients.

Key facts

Sponsor
Vaestra Goetalandsregionen
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Cardiovascular Diseases [C14]
Trial duration
8 Jun 2018 → ongoing
Decision date (initial)
2024-10-23
Transition trial
Yes
Low-intervention
No
Rare-disease indication
No
Vulnerable population
No
Funding sources
Vastra Gotaland Region · The Swedish Heart-Lung Foundation, a non-profit organization. There is no commercial funding · The Swedish Research Council, a governmental institution

External identifiers

EU CT number
2023-508551-40-00
EudraCT number
2017-001499-43
ClinicalTrials.gov
NCT03560310

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Therapy, Efficacy

To assess whether dual antiplatelet therapy (DAPT) with ticagrelor and ASA compared to ASA alone improves 12 months
outcome defined as major adverse cardiovascular events (MACE) after isolated Coronary Artery Bypass Grafting (CABG) in
Acute Coronary Syndrome (ACS) patients.

Conditions and MedDRA coding

Coronary artery multi-vessel disease and left main stenosis

VersionLevelCodeTermSystem organ class
20.0 LLT 10013098 Disease coronary artery 10007541

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

  1. Written informed consent
  2. Age ≥18 years
  3. Has undergone first time isolated CABG due to an episode of acute coronary syndrome (STEMI, NSTEMI, unstable angina) within 6 weeks before surgery

Exclusion criteria 17

  1. Previously enrolled in this study (i.e. patient now at repeat encounter)
  2. Concomitant surgical procedure other than CABG
  3. Anticoagulant treatment after the operation (e.g. warfarin, direct thrombin inhibitors (dabigatran), FXa inhibitors (rivaroxaban, apixaban, heparin, low-molecular weight heparin, fondaparinux)
  4. Discharge from the operating hospital to an ICU at another hospital
  5. Pregnancy or lactation
  6. Known intolerance or contraindication to ticagrelor or ASA
  7. Any disorder that may interfere with drug absorption
  8. Any condition other than coronary artery disease with a life expectancy <12 months
  9. Known chronic liver disease, renal disease requiring dialysis or bleeding disorder
  10. AV-block II and III in patients without pacemaker
  11. Any other indication for dual antiplatelet therapy, i.e. recent stent implantation
  12. Debilitating stroke within 90 days before inclusion
  13. Previous intracranial bleeding
  14. Treatment with immunosuppressants (e.g. cyclosporine and tacrolimus)
  15. Treatment with strong CYP3A4-inhibitors (e.g. ketoconazole, clarithromycin, nefazodon, ritonavir or atazanavir)
  16. Any condition that in the opinion of the investigator may interfere with adherence to trial protocol
  17. Participation in any other clinical trial evaluating investigational products at the time for enrollment in this study

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. A composite endpoint of the time to all cause death, or myocardial infarction, or stroke, or new coronary revascularization within 12 months

Secondary endpoints 11

  1. Time to all cause death
  2. Time to all cause death, myocardial infarction or stroke
  3. Time to cardiovascular death
  4. Time to first myocardial infarction
  5. Time to first stroke
  6. Time to new revascularization
  7. Time to coronary angiography
  8. Time to hospitalization for heart failure
  9. Time to cardiovascular hospitalization
  10. Time to sudden death or aborted cardiac arrest
  11. Time to new-onset AF

Investigational products

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

Test 6

Ticagrelor

SUB30898 · Substance

Active substance
Ticagrelor
Pharmaceutical form
TABLET
Route of administration
GASTROENTERAL USE
Max daily dose
180 mg milligram(s)
Max total dose
68220 mg milligram(s)
Max treatment duration
379 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Acetylsalicylic Acid

SUB12730MIG · Substance

Active substance
Acetylsalicylic Acid
Pharmaceutical form
TABLET
Route of administration
GASTROENTERAL USE
Max daily dose
160 mg milligram(s)
Max total dose
60640 mg milligram(s)
Max treatment duration
379 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Acetylsalicylic Acid

SUB12730MIG · Substance

Active substance
Acetylsalicylic Acid
Pharmaceutical form
TABLET
Route of administration
GASTROENTERAL USE
Max daily dose
160 mg milligram(s)
Max total dose
60640 mg milligram(s)
Max treatment duration
379 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Acetylsalicylic Acid

SUB12730MIG · Substance

Active substance
Acetylsalicylic Acid
Pharmaceutical form
TABLET
Route of administration
GASTROENTERAL USE
Max daily dose
160 mg milligram(s)
Max total dose
60640 mg milligram(s)
Max treatment duration
379 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Acetylsalicylic Acid

SUB12730MIG · Substance

Active substance
Acetylsalicylic Acid
Pharmaceutical form
TABLET
Route of administration
GASTROENTERAL USE
Max daily dose
160 mg milligram(s)
Max total dose
60640 mg milligram(s)
Max treatment duration
379 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Acetylsalicylic Acid

SUB12730MIG · Substance

Active substance
Acetylsalicylic Acid
Pharmaceutical form
TABLET
Route of administration
GASTROENTERAL USE
Max daily dose
160 mg milligram(s)
Max total dose
60640 mg milligram(s)
Max treatment duration
379 Week(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

Vaestra Goetalandsregionen

39 Total trials 20 Recruiting 12 Ended
Academic / Non-commercial
Sponsor organisation
Vaestra Goetalandsregionen
Address
Regionens Hus
City
Vänersborg
Postcode
462 80
Country
Sweden

Scientific contact point

Organisation
Vaestra Goetalandsregionen
Contact name
Anders Jeppsson

Public contact point

Organisation
Vaestra Goetalandsregionen
Contact name
Anders Jeppsson

Third parties 1

OrganisationCity, countryDuties
Frederiksberg Hospital
ORG-100028217
 Frederiksberg, Denmark On site monitoring

Locations

5 EU/EEA countries · 22 investigational sites

By country

CountryMS statusPlanned subjectsSites
Denmark Ongoing, recruitment ended 400 4
Finland Ongoing, recruitment ended 200 5
Iceland Ongoing, recruitment ended 100 1
Norway Ongoing, recruitment ended 400 4
Sweden Ongoing, recruitment ended 1,100 8
Rest of world — 0 —

Investigational sites

Denmark

4 sites · Ongoing, recruitment ended
Aalborg University Hospital
Clinic for Anaesthesiology, Child Diseases, Circulation and Women, Hobrovej 18-22, 9000 Aalborg, Hobrovej 18-22, 9000, Aalborg
Aarhus Universitetshospital
Department of Cardiothoracic and Vascular Surgery, Palle Juul-Jensens Boulevard 99, DK-8200 Aarhus N, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N
Rigshospitalet
Department of Thoracic Surgery, Section 2152, Inge Lehmanns Vej 7, 2100 Copenhagen Ø, Inge Lehmanns Vej 7, 2100, Copenhagen Oe
Odense University Hospital
Department T of Cardio, Vascular and Thoracic surgery, J B Winsloews Vej 4, 5000 Odense C, J B Winsloews Vej 4, 5000, Odense C

Finland

5 sites · Ongoing, recruitment ended
Meilahti Hospital
Helsinki University Hospital, Heart and Lung Center, Haaermaninkatu 4, PL 340, 0029 HUS, Helsinki, P. O. Box 340, 00029, Helsinki
Turku University Hospital
Hospital District of South-West Finland, Heart Center TYKS Kiinanmyllynkatu 4-8 20520 Turku, Kiinamyllynkatu 4-8, 20520, Turku
Oulu University Hospital
Department Operative Care, P.O. box 21 90029, OYS Finland, Kajaanintie 50, 90220 Oulu, Kajaanintie 50, 90220, Oulu
Kuopio University Hospital
KYS,NorthernSavoHospital,DistrictMunicipalFederation,Dept Heart Center,Puijonlaaksontie2,7021 Kuopio, Puijonlaaksontie 2, P. O. Box 1777, Kuopio
TAYS Sydaenkeskus Oy
Department Heart Center, TAYS Sydänkeskus Oy, P. O. Box 2000, 33521 Tampere, P. O. Box 2000, 33521, Tampere

Iceland

1 site · Ongoing, recruitment ended
Landspitali
TheNationalUniversityHospitalofIceland, Dept of Cardiothoracic Surgery, Hringbraut 101,105 Reykjavik, Hringbraut 101, 101, Reykjavik

Norway

4 sites · Ongoing, recruitment ended
St. Olavs Hospital HF
St. Olavs hospital, Department of Cardiothoracic Surgery, Prinsesse Kristinas gt. 3, 7030 Trondheim, Prinsesse Kristinas G. 3, 7030, Trondheim
Helse Bergen HF
Haukeland University Hospital, Department of Thoracic Surgery, Jonas Lies vei 65, 5021 Bergen, Jonas Lies Vei 65, 5021, Bergen
Oslo University Hospital HF
Department of Cardiothoracic Surgery, Postboks 4950 Nydalen, 0424 Oslo, P. O. Box 4950, 0424, Oslo
Universitetssykehuset Nord-Norge HF
Departement of Cardiothoracic and Vascular surgery, Hansine Hansens veg 67, 9019 Tromsø, Hansine Hansens Veg 67, 9019, Tromsoe

Sweden

8 sites · Ongoing, recruitment ended
Sahlgrenska University Hospital-Vastra Gotalandsregionen
Department of Cardiothoracic surgery, Blå stråket 5, 413 45 Gothenburg, Sweden, Bla Straket 5, 413 46, Goteborg
Region Oerebro Laen
Department of Cardiothoracic and vascular surgery, Södra Grevrosengatan, 701 85 Örebro, Sweden, Sodra Grev Rosengatan, 701 85, Orebro
Region Skane Skanes Universitetssjukhus
Department of Cardiothoracic Surgery, 221 85 Lund, Sweden, Entregatan 7, 222 42, Lund
Region Blekinge
Department of Cardiothoracic Surgery, 371 41 Karlskrona, Sweden, Lasarettsvagen, 371 85, Karlskrona
Region Oestergoetland
Department of Cardiothoracic surgery, Heart and Medicine center, 581 85 Linköping, Sweden, Universitetssjukhuset I Linkoping, 581 85, Linkoping
Karolinska University Hospital
Heart & Vascular Theme, 171 76 Stockholm, Sweden, Eugeniavagen 3, 171 64, Solna
Uppsala University Hospital
Department of Thoracic and Cardiovascular Surgery, 751 85 Uppsala, Sweden, Akademiska Sjukhuset, 751 85, Uppsala
Region Vaesterbotten
Department of Public Health and clinical Medicine, Heart Center, 901 85 Umeå, Sweden, Umea University, 901 85, Umea

Country notifications

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

Country Trial startTrial end Recruitment startRecruitment end Early termination
Denmark 2019-09-27 2019-11-29 2024-02-28
Finland 2020-10-22 2020-11-27 2024-02-14
Iceland 2020-06-23 2020-06-29 2023-12-15
Norway 2019-08-27 2019-11-28 2024-02-26
Sweden 2018-06-08 2018-06-29 2024-02-22

Results and documents

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

Documents 14 files

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

TypeTitleVersion
Protocol (for publication) D1_Protocol_2023-508551-40-00 7
Recruitment arrangements (for publication) _Placeholder_transitional_trial 1
Recruitment arrangements (for publication) _Placeholder_transitional_trial 1
Recruitment arrangements (for publication) _Placeholder_transitional_trial 1
Recruitment arrangements (for publication) _Placeholder_transitional_trial 1
Recruitment arrangements (for publication) _Placeholder_transitional_trial 1
Subject information and informed consent form (for publication) L1_Forsokspersonsinformation_samtycke_2023-508551-40-00_Sverige 1
Subject information and informed consent form (for publication) L1_Subject_Info_and_ICF_2023-508551-40-00_Denmark 1
Subject information and informed consent form (for publication) L1_Subject_Info_and_ICF_2023-508551-40-00_Finland 1
Subject information and informed consent form (for publication) L1_Subject_Info_and_ICF_2023-508551-40-00_Finland_Swedish text 1
Subject information and informed consent form (for publication) L1_Subject_Info_and_ICF_2023-508551-40-00_Iceland 1
Subject information and informed consent form (for publication) L1_Subject_Info_and_ICF_2023-508551-40-00_Norway 2.3
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC_ASA 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC_Brilique 1

Application history

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

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-09-24 Sweden Acceptable
2024-10-23
 2024-10-23

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