Ticagrelor and ASA vs. ASA Only After Isolated Coronary Artery Bypass Grafting in Patients With Acute Coronary Syndrome

NCT ID: NCT03560310

Last Updated: 2025-09-02

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 2201 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-29
• Study Completion Date: 2035-02-15

Brief Summary

The study is a Randomised Registry-based Clinical Trial (RRCT) to assess whether dual antiplatelet therapy with ticagrelor and ASA compared to ASA alone improves outcome after isolated CABG in patients with acute coronary syndrome.

Detailed Description

The trial is a 1:1 randomized, interventional, multi-national, multi-center, safety/efficacy, parallel assignment, open-label treatment study and will use the RRCT methodology. A RRCT study utilizes existing health care registry platforms to conduct a pragmatic prospective randomized trial.

After the CABG, eligible patients that have consented to the study, will be randomized to either treatment arms. In the intervention arm, patients will be treated with ticagrelor 90 mg twice daily and ASA 75-100 mg daily for 12 months and patients in the control arm will get ASA only (75-160 mg daily according to local guidelines) during the same time period.

The patients will be followed by telephone interviews at 30 days and 365 days after inclusion. After the treatment period patients will be followed during an observation period by collection of outcome data from registries or medical records, 24, 36, 60 and 120 months after inclusion of the patient. No other data but the registry data or data from medical records will be collected.

Conditions

Acute Coronary Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dual antiplatelet therapy

Ticagrelor 90 mg twice daily and ASA 75-100 mg daily for 12 months

Group Type: EXPERIMENTAL

Ticagrelor 90mg twice daily and ASA 75-100 mg daily

Intervention Type: DRUG

Assess whether ticagrelor 90 mg twice daily and ASA 75-100 mg daily versus ASA 75-160 mg daily improves outcome after isolated coronary artery bypass grafting in patients with acute coronary syndrome

Acetylsalicylic acid

ASA 75-160 mg daily for 12 months

Group Type: ACTIVE_COMPARATOR

ASA 75-160 mg daily

Intervention Type: DRUG

Assess whether ticagrelor 90 mg twice daily and ASA 75-100 mg daily versus ASA 75-160 mg daily improves outcome after isolated coronary artery bypass grafting in patients with acute coronary syndrome

Interventions

Ticagrelor 90mg twice daily and ASA 75-100 mg daily

Assess whether ticagrelor 90 mg twice daily and ASA 75-100 mg daily versus ASA 75-160 mg daily improves outcome after isolated coronary artery bypass grafting in patients with acute coronary syndrome

Intervention Type: DRUG

ASA 75-160 mg daily

Assess whether ticagrelor 90 mg twice daily and ASA 75-100 mg daily versus ASA 75-160 mg daily improves outcome after isolated coronary artery bypass grafting in patients with acute coronary syndrome

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

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. Atrioventricular 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, nefazodone, 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gothia Forum - Center for Clinical Trial

OTHER

Sponsor Role: collaborator

Göteborg University

OTHER

Sponsor Role: collaborator

Vastra Gotaland Region

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anders Jeppssson, MD,PhD,Prof.

Role: PRINCIPAL_INVESTIGATOR

Dep. of Cardiothoracic Surgery , Sahlgrenska University Hospital, 413 45 Gothenburg, Sweden

Locations

Aalborg University Hospital

Aalborg, , Denmark

Aarhus University Hospital

Aarhus, , Denmark

Rigshospitalet

Copenhagen, , Denmark

Odense University Hospital

Odense, , Denmark

Helsinki University Hospital

Helsinki, , Finland

Kuopio University Hospital

Kuopio, , Finland

Oulu University Hospital

Oulu, , Finland

Tampere University Hospital

Tampere, , Finland

Turku University Hospital

Turku, , Finland

Landspítali University Hospital

Reykjavik, , Iceland

St. Olavs hospital, University Hospital

Bergen, , Norway

Oslo University Hospital

Oslo, , Norway

University Hospital of North Norway

Tromsø, , Norway

Haukeland University Hospital

Trondheim, , Norway

Sahlgrenska University Hospital

Gothenburg, , Sweden

Blekinge Hospital

Karlskrona, , Sweden

Linköping University Hospital

Linköping, , Sweden

Skåne University Hospital

Lund, , Sweden

Örebro University Hospital

Örebro, , Sweden

Karolinska University Hospital

Stockholm, , Sweden

University Hospital of Umeå

Umeå, , Sweden

Uppsala University Hospital

Uppsala, , Sweden

Countries

Denmark; Finland; Iceland; Norway; Sweden

References

Jeppsson A, James S, Moller CH, Malm CJ, Dalen M, Vanky F, Modrau IS, Andersen K, Anttila V, Atroshchenko GV, Barbu M, Dreifaldt M, El-Akkawi AI, Friberg O, Gudbjartsson T, Gunn J, Haaverstad R, Halonen J, Hansson EC, Holm J, Husso A, Juvonen T, Jakobsen O, Jideus L, Johannesson E, Jonsson Holmdahl A, Jonsson K, Kolseth SM, Krasniqi L, Makela T, Mennander A, Mohagen Krogstad LE, Rafiq S, Raivio P, Riber L, Tahir A, Thorsen C, Tonnessen T, Wahba A, Zindovic I, Pivodic A, Nielsen SJ, Erlinge D, Alfredsson J, Sartipy U; TACSI Trial Group.. Ticagrelor and Aspirin or Aspirin Alone after Coronary Surgery for Acute Coronary Syndrome. N Engl J Med. 2025 Sep 1. doi: 10.1056/NEJMoa2508026. Online ahead of print.

Reference Type: DERIVED

PMID: 40888737 (View on PubMed)

Malm CJ, Alfredsson J, Erlinge D, Gudbjartsson T, Gunn J, James S, Moller CH, Nielsen SJ, Sartipy U, Tonnessen T, Jeppsson A. Dual or single antiplatelet therapy after coronary surgery for acute coronary syndrome (TACSI trial): Rationale and design of an investigator-initiated, prospective, multinational, registry-based randomized clinical trial. Am Heart J. 2023 May;259:1-8. doi: 10.1016/j.ahj.2023.01.011. Epub 2023 Jan 18.

Reference Type: DERIVED

PMID: 36681173 (View on PubMed)

Other Identifiers

EudraCT 2017-001499-43

Identifier Type: -

Identifier Source: org_study_id