The purpose of this study is to compare the effect of prasugrel plus low-dose aspirin versus high dose aspirin alone (300mg) and versus low dose aspirin alone (75 mg) in patients with chronic coronary disease undergoing coronary artery bypass grafting.
Age >18 years
Primary isolated CABG patients with stable coronary artery disease (chronic coronary syndrome) planned for at least 2 grafts. Coronary artery disease will be defined as a stenosis ≥ 70% based on coronary angiography, a FFR value ≤ 0.80 or iFr value ≤0.89; a left main diameter stenosis ≥ 50%, left main IVUS MLA value ≤ 6 mm2, or equivalent OCT measurements will also be considered.
Ability to comply with all study procedures and follow-up procedures
Signed Informed Consent to participate in the study.
Cardiogenic shock
Patients with recent acute coronary syndrome (ACS) (<12 months)
Single vessel CABG
Patients with preoperative atrial fibrillation
Parallel
High-Dose Aspirin 300 mg
DrugHigh-dose Aspirin 300 mg once daily taken orally for three months
DAPT (Low-Dose Aspirin 75 mg + Prasugrel 10 mg)
DrugDrug: Prasugrel 10 mg Prasugrel 10 mg once daily taken orally for 3 months Drug: Low-Dose Aspirin 75 mg once daily taken orally
Low-Dose Aspirin 75 mg
DrugLow-Dose Aspirin 75 mg once daily taken orally
Incidence of graft failure: DAPT vs Low-Dose Aspirin and DAPT vs High-Dose Aspirin
Incidence of graft failure defined according to Fitzgibbon classification (Fitzgibbon Class B + O) 12 months after the randomization following CABG in patients with DAPT (prasugrel 10mg/day + low dose aspirin 75mg/day) versus high-dose aspirin (300mg/day) and in patients with DAPT (prasugrel 10mg/day + low dose aspirin 75mg/day) vs low-dose aspirin (75mg/day)
Key secondary outcome: Incidence of graft failure: High-Dose Aspirin vs Low-Dose Aspirin
Incidence of graft failure defined according to Fitzgibbon classification (Fitzgibbon Class B + O) 12 months after the randomization following CABG in patients with high-dose aspirin (300mg/day) vs low-dose aspirin (75mg/day)
investigatigating the effect of DAPT versus low-dose aspirin, DAPT versus high-dose aspirin and low-dose aspirin versus high-dose aspirin on the 12-month risk of ischemic events after CABG
Major adverse cardiac and cerebral events (MACCE) is a composite endpoint to be compared between groups defined as composite of: 1. All-cause mortality 2. Incidence of myocardial infarction 3. Incidence of stroke 4. Incidence of repeat revascularization
Investigatigating the effect of DAPT versus low-dose aspirin, DAPT versus high-dose aspirin and low-dose aspirin versus high-dose aspirin on the 12-month risk of bleeding events after CABG
Incidence of bleeding within 12 months after randomization following CABG procedure according to the Bleeding Academic Research Consortium (BARC) type 2, 3 or 5
Investigatigating the effect of DAPT versus low-dose aspirin, DAPT versus high-dose aspirin and low-dose aspirin versus high-dose aspirin on quality of life at 6 and 12 months after CABG.
Quality of life will be assessed using quality of life questionnaires at baseline, 6 and 12 months after randomization following CABG procedure and will be evaluated using The Seattle Angina Questionnaire - 7 (SAQ-7) and Short-form-12 health survey questionnaire (SF-12)
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Dolnośląskie Centrum Chorób Serca im.prof. Zbigniewa Religi MEDINET Sp. z o.o.
Lead sponsor
Medical Research Agency, Poland
Collaborator
