EUCTR2017-001499-43-SEActive, not recruitingPhase 1
Dual antiplatelet therapy with ticagrelor and acetylsalicylic acid (ASA) vs. ASA only after isolated coronary artery bypass grafting in patients with acute coronary syndrome (TACSI trial) - TACSI
Sahlgrenska University Hospital0 sites2,200 target enrollmentStarted: July 19, 2017Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 2,200
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
- •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
Investigators
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