Comparing a combination therapy of Brilique and Trombyl against Trombyl as single therapy after bypass surgery in patients with myocardial infarction or instable angina.

Phase 1

• Conditions: 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; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2017-001499-43-FI
• Lead Sponsor: Sahlgrenska University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-05-07
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 2200

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified