Coronary artery multi-vessel disease and left main stenosis MedDRA version: 20.0 Level: LLT Classification code 10011098 Term: Coronary bypass System Organ Class: 100000004865
Conditions
Interventions
Trade Name: Brilique
Pharmaceutical Form: Tablet
INN or Proposed INN: Ticagrelor
Other descriptive name: Ticagrelor
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number:
Sponsors
Sahlgrenska University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1100
Exclusion criteria
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 or bleeding disorder • AV-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 • Treatment with immunosuppressants (e.g. cyclosporine and tacrolimus) • Treatment with strong CYP3A4-inhibitors (e.g. ketoconazole, clarithromycin, nefazodon, ritonavir or atazanavir) • Any condition that in the opinion of the investigator may interfere with adherence to trial protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess whether dual antiplatelet therapy (DAPT) with ticagrelor and ASA compared to ASA alone improves 12 months outcome defined as major adverse cardiovascular events (MACE) after isolated Coronary Artery Bypass Grafting (CABG) in Acute Coronary Syndrome (ACS) patients.;Secondary Objective: 1. All cause of mortality. 2. Hospitalization with relevant ICD-10 codes obtained from the National Patent Registries. 3. New onset morbidity: A new diagnosis during follow-up, with relevant ICD-10 code in any position, in patients who were free from this diagnosis at baseline (the relevant ICD-10 code never previously recorded in any position). 4. Persistance to treatment assignment (ticagrelor+ASA or ASA alone) obtained from the Dispensed Drug Registry.;Primary end point(s): Time to all cause death, or myocardial infarction, or stroke, or new revascularization ;Timepoint(s) of evaluation of this end point: within 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Time to all cause death - Time to all cause death, myocardial infarction or stroke - Time to cardiovascular death - Time to first myocardial infarction - Time to first stroke - Time to new revascularization - Time to coronary angiography - Time to hospitalization for heart failure - Time to acute cardiovascular hospitalization - Time to sudden death or aborted cardiac arrest - Time to new-onset AF;Timepoint(s) of evaluation of this end point: 12 months and follow up at 2, 3 , 5 and 10 years | — |
Countries
Denmark, Finland, Iceland, Norway, Sweden
Contacts
Public ContactDept of Cardiothoracic Surgery
Sahlgrenska University Hospital
Outcome results
None listed