Comparing a combination therapy of Brilique and Trombyl against Trombyl as single therapy after bypass surgery in patients with myocardial infarction or instable angina.
- Conditions
- Coronary artery multi-vessel disease and left main stenosisMedDRA version: 20.0Level: LLTClassification code 10011098Term: Coronary bypassSystem Organ Class: 10042613 - Surgical and medical proceduresTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2017-001499-43-IS
- Lead Sponsor
- Sahlgrenska University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- 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
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
• 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
Participation in any other clinical trial evaluating investigational Products at the time of enrollment in this study
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method