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

Last updated: September 2, 2024
Sponsor: Vastra Gotaland Region
Overall Status: Active - Not Recruiting

Phase

4

Condition

Coronary Artery Disease

Chest Pain

Cardiac Ischemia

Treatment

ASA 75-160 mg daily

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

Clinical Study ID

NCT03560310
EudraCT 2017-001499-43
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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 thrombininhibitors (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 adherenceto trial protocol

  17. Participation in any other clinical trial evaluating investigational products at thetime for enrollment in this study

Study Design

Total Participants: 2203
Treatment Group(s): 2
Primary Treatment: ASA 75-160 mg daily
Phase: 4
Study Start date:
June 29, 2018
Estimated Completion Date:
February 15, 2035

Study 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.

Connect with a study center

  • Aalborg University Hospital

    Aalborg,
    Denmark

    Site Not Available

  • Aarhus University Hospital

    Aarhus,
    Denmark

    Site Not Available

  • Rigshospitalet

    Copenhagen,
    Denmark

    Site Not Available

  • Odense University Hospital

    Odense,
    Denmark

    Site Not Available

  • Helsinki University Hospital

    Helsinki,
    Finland

    Site Not Available

  • Kuopio University Hospital

    Kuopio,
    Finland

    Site Not Available

  • Oulu University Hospital

    Oulu,
    Finland

    Site Not Available

  • Tampere University Hospital

    Tampere,
    Finland

    Site Not Available

  • Turku University Hospital

    Turku,
    Finland

    Site Not Available

  • Landspítali University Hospital

    Reykjavík,
    Iceland

    Site Not Available

  • St. Olavs hospital, University Hospital

    Bergen,
    Norway

    Site Not Available

  • Oslo University Hospital

    Oslo,
    Norway

    Site Not Available

  • University Hospital of North Norway

    Tromsø,
    Norway

    Site Not Available

  • Haukeland University Hospital

    Trondheim,
    Norway

    Site Not Available

  • Sahlgrenska University Hospital

    Gothenburg,
    Sweden

    Site Not Available

  • Blekinge Hospital

    Karlskrona,
    Sweden

    Site Not Available

  • Linköping University Hospital

    Linköping,
    Sweden

    Site Not Available

  • Skåne University Hospital

    Lund,
    Sweden

    Site Not Available

  • Karolinska University Hospital

    Stockholm,
    Sweden

    Site Not Available

  • University Hospital of Umeå

    Umeå,
    Sweden

    Site Not Available

  • Uppsala University Hospital

    Uppsala,
    Sweden

    Site Not Available

  • Örebro University Hospital

    Örebro,
    Sweden

    Site Not Available

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