Acute Coronary Syndrome
Conditions
Keywords
Coronary Bypass Grafting, Antiplatelet treatment
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.
Interventions
DRUGTicagrelor 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
DRUGASA 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
Sponsors
Gothia Forum - Center for Clinical Trial
Göteborg University
Vastra Gotaland Region
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Parallel treatment arms.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to major adverse cardiovascular events (MACE) | 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
| Measure | Time frame | Description |
|---|---|---|
| Time to all cause death, myocardial infarction or stroke | 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. |
| Time to cardiovascular death | 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 |
| Time to first myocardial infarction | 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 |
| Time to first stroke | 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 |
| Time to new revascularization | 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 |
| Time to coronary angiography | 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 |
| Time to hospitalization for heart failure | 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 |
| Time to cardiovascular hospitalization | 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 |
| Time to all cause death | 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 |
| Time to new-onset atrial fibrillation | 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 |
| Time to major bleeding defined as bleeding requiring hospitalization | 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 |
| Time to minor bleeding | 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 |
| Time to any bleeding | 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 |
| Time to dyspnea | 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 |
| Time to dyspnea causing drug interruption | 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 |
| Time to new onset renal failure | 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 |
| Time to major adverse cardiovascular events (MACE) | 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. |
| Time to sudden death or aborted cardiac arrest | 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 |
Countries
Denmark, Finland, Iceland, Norway, Sweden
Outcome results
None listed