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.
This is a multicenter, randomized trial evaluating the effect of low-dose aspirin plus prasugrel versus low-dose ASA and versus high-dose ASA for three months, followed by low-dose ASA alone, on graft failure at 12 months in patients with stable coronary artery disease (chronic coronary syndrome) following a coronary artery bypass grafting.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
1,703
High-dose Aspirin 300 mg once daily taken orally for three months
Drug: 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 once daily taken orally
University Clinical Hospital in Bialystok
Bialystok, Poland
NOT_YET_RECRUITINGNicolaus Copernicus University Ludwik Rydygier Collegium Medicum in Bydgoszcz
Bydgoszcz, Poland
NOT_YET_RECRUITINGMedical University of Gdansk
Gdansk, Poland
NOT_YET_RECRUITINGRegional Specialist Hospital in Grudziadz
Grudziądz, Poland
NOT_YET_RECRUITINGUpper-Silesian Heart Center
Katowice, Poland
NOT_YET_RECRUITINGJohn Paul II Hospital
Krakow, Poland
NOT_YET_RECRUITINGMedical University of Lodz
Lodz, Poland
NOT_YET_RECRUITINGZbigniew Religa Heart Center "Medinet"
Nowa Sól, Poland
RECRUITINGProvincial Specialist Hospital in Olsztyn
Olsztyn, Poland
NOT_YET_RECRUITINGInstitute of Medical Sciences in Opole
Opole, Poland
NOT_YET_RECRUITING...and 8 more locations
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)
Time frame: 12 months
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)
Time frame: 12 months
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
Time frame: 12 months
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
Time frame: 12 months
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)
Time frame: 12 months
investigatigating the effect of DAPT versus low-dose aspirin, DAPT versus high-dose aspirin and low-dose aspirin versus high-dose aspirin on the 60-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
Time frame: 60 months
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