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NCT Number: NCT03560310

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Acute Coronary Syndrome Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Aalborg University Hospital, Aalborg, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Written informed consent
  • Age ≥18 years
  • 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

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

Treatment and study plan

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

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

ASA 75-160 mg daily

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

Primary outcomes

  1. Time to major adverse cardiovascular events (MACE)

    Time frame: within12 months

    To assess whether dual antiplatelet therapy (DAPT) with ticagrelor and ASA compared to single antiplatelet therapy with ASA alone improves 12 months outcome defined as time to major adverse cardiovascular events (MACE) after isolated CABG in ACS patients. MACE includes all-cause mortality, myocardial infarction, stroke and new revascularization.

Secondary outcomes

  1. Time to all cause death

    Time frame: within 12 months

    To assess whether dual antiplatelet therapy (DAPT) with ticagrelor and ASA compared to single antiplatelet therapy with ASA alone influences all cause death within 12 months after randomization

  2. Time to all cause death, myocardial infarction or stroke

    Time frame: within 12 months

    To assess whether dual antiplatelet therapy (DAPT) with ticagrelor and ASA compared to single antiplatelet therapy with ASA alone improves 12 months outcome defined as time to a composite endpoint of all cause death, myocardial infarction or stroke after isolated CABG in ACS patients.

  3. Time to cardiovascular death

    Time frame: within 12 months

    To assess whether dual antiplatelet therapy (DAPT) with ticagrelor and ASA compared to single antiplatelet therapy with ASA alone influences cardiovascular death within 12 months after randomization

  4. Time to first myocardial infarction

    Time frame: within 12 months

    To assess whether dual antiplatelet therapy (DAPT) with ticagrelor and ASA compared to single antiplatelet therapy with ASA alone influences myocardial infarction within 12 months after randomization

  5. Time to first stroke

    Time frame: within 12 months

    To assess whether dual antiplatelet therapy (DAPT) with ticagrelor and ASA compared to single antiplatelet therapy with ASA alone influences the incidence of stroke within 12 months after randomization

  6. Time to new revascularization

    Time frame: within 12 months

    To assess whether dual antiplatelet therapy (DAPT) with ticagrelor and ASA compared to single antiplatelet therapy with ASA alone influences the incidence of new revascularization within 12 months after randomization

  7. Time to coronary angiography

    Time frame: within 12 months

    To assess whether dual antiplatelet therapy (DAPT) with ticagrelor and ASA compared to single antiplatelet therapy with ASA alone influences the incidence of coronary angiography within 12 months after randomization

  8. Time to hospitalization for heart failure

    Time frame: within 12 months

    To assess whether dual antiplatelet therapy (DAPT) with ticagrelor and ASA compared to single antiplatelet therapy with ASA alone influences the incidence of heart failure within 12 months after randomization

  9. Time to cardiovascular hospitalization

    Time frame: within 12 months

    To assess whether dual antiplatelet therapy (DAPT) with ticagrelor and ASA compared to single antiplatelet therapy with ASA alone influences the incidence of cardiovascular hospitalization within 12 months after randomization

  10. Time to sudden death or aborted cardiac arrest

    Time frame: within 12 months

    To assess whether dual antiplatelet therapy (DAPT) with ticagrelor and ASA compared to single antiplatelet therapy with ASA alone influences the incidence of sudden death or aborted cardiac arrest within 12 months after randomization

  11. Time to new-onset atrial fibrillation

    Time frame: within 12 months

    To assess whether dual antiplatelet therapy (DAPT) with ticagrelor and ASA compared to single antiplatelet therapy with ASA alone influences the incidence of new-onset atrial fibrillation within 12 months after randomization

  12. Time to major bleeding defined as bleeding requiring hospitalization

    Time frame: within 12 months

    To assess whether dual antiplatelet therapy (DAPT) with ticagrelor and ASA compared to single antiplatelet therapy with ASA alone influences the incidence of major bleeding within 12 months after randomization

  13. Time to minor bleeding

    Time frame: within 12 months

    To assess whether dual antiplatelet therapy (DAPT) with ticagrelor and ASA compared to single antiplatelet therapy with ASA alone influences the incidence of minor bleeding within 12 months after randomization

  14. Time to any bleeding

    Time frame: within 12 months

    To assess whether dual antiplatelet therapy (DAPT) with ticagrelor and ASA compared to single antiplatelet therapy with ASA alone influences the incidence of any bleeding within 12 months after randomization

  15. Time to dyspnea

    Time frame: within 12 months

    To assess whether dual antiplatelet therapy (DAPT) with ticagrelor and ASA compared to single antiplatelet therapy with ASA alone influences the incidence of dyspnea within 12 months after randomization

  16. Time to dyspnea causing drug interruption

    Time frame: within 12 months

    To assess whether dual antiplatelet therapy (DAPT) with ticagrelor and ASA compared to single antiplatelet therapy with ASA alone influences the incidence of dyspnea causing drug interruption within 12 months after randomization

  17. Time to new onset renal failure

    Time frame: within 12 months

    To assess whether dual antiplatelet therapy (DAPT) with ticagrelor and ASA compared to single antiplatelet therapy with ASA alone influences the incidence of new onset renal failure within 12 months after randomization

  18. Time to major adverse cardiovascular events (MACE)

    Time frame: 2, 3, 5 and 10 years after the patient has been included in the study

    To assess whether dual antiplatelet therapy (DAPT) with ticagrelor and ASA compared to single antiplatelet therapy with ASA alone improves long-term outcome defined as time to major adverse cardiovascular events (MACE) after isolated CABG in ACS patients. MACE includes all-cause mortality, myocardial infarction, stroke and new revascularization.

Sponsors and collaborators

Lead sponsor

Vastra Gotaland Region

Other Gov

Collaborators

  • Gothia Forum - Center for Clinical Trial
  • Göteborg University

Registry information

Official study title

Dual Antiplatelet Therapy With Ticagrelor and Acetylsalicylic Acid (ASA) vs. ASA Only After Isolated Coronary Artery Bypass Grafting in Patient With Acute Coronary Syndrome

Acronym: TACSI

Important dates

Study start
2018
Primary completion
2025
Study completion
2035
First posted
Jun 18, 2018
Registry last updated
Sep 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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