Ticagrelor and ASA vs. ASA Only After Isolated Coronary Artery Bypass Grafting in Patients With Acute Coronary Syndrome
- Conditions
- Acute Coronary Syndrome
- Interventions
- Registration Number
- NCT03560310
- Lead Sponsor
- Vastra Gotaland Region
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 2200
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dual antiplatelet therapy Ticagrelor 90mg twice daily and ASA 75-100 mg daily Ticagrelor 90 mg twice daily and ASA 75-100 mg daily for 12 months Acetylsalicylic acid ASA 75-160 mg daily ASA 75-160 mg daily for 12 months
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 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 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
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 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 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 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 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.
Trial Locations
- Locations (22)
University Hospital of North Norway
🇳🇴Tromsø, Norway
Haukeland University Hospital
🇳🇴Trondheim, Norway
Sahlgrenska University Hospital
🇸🇪Gothenburg, Sweden
Blekinge Hospital
🇸🇪Karlskrona, Sweden
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
🇮🇸Reykjavík, Iceland
St. Olavs hospital, University Hospital
🇳🇴Bergen, Norway
Oslo University Hospital
🇳🇴Oslo, Norway
Linköping University Hospital
🇸🇪Linköping, Sweden
Skåne University Hospital
🇸🇪Lund, Sweden
Karolinska University Hospital
🇸🇪Stockholm, Sweden
University Hospital of Umeå
🇸🇪Umeå, Sweden
Uppsala University Hospital
🇸🇪Uppsala, Sweden
Örebro University Hospital
🇸🇪Örebro, Sweden