Primary isolated CABG patients with stable coronary artery disease (chronic coronary syndrome) planned for at least 2 grafts.
Conditions
Brief summary
The assessment of the proportion of failed grafts is defined according to Fitzgibbon classification (Fitzgibbon Class B + O) 12 months after the randomization following CABG procedure in patients with DAPT with prasugrel (10mg/day) plus ASA (75mg/day) vs high-dose ASA (300mg/d) and DAPT vs low-dose ASA (75mg/day)
Detailed description
The assessment of the proportion of failed grafts defined according to Fitzgibbon classification (Fitzgibbon Class B + O) 12 months after the randomization following CABG procedure, in patients receiving high- (300mg/d) vs low-dose ASA (75mg/day)., A safety and efficacy assessment of use of the investigational products, based on the frequency of reported adverse events during the first 6 and 12 and long term follow up months after randomization., a) All-cause mortality at 12 months in the three groups, b) Incidence of myocardial infarction in the three groups, c) Incidence of stroke in the three groups, d) Incidence of repeat revascularization in the three groups, e) Incidence of MACCE (composite mortality, myocardial infarction, stroke and repeat revascularization) at 12 months and beyond 12 months in the three groups, f) Safety of treatment in terms of the incidence of bleeding within 12 months according to the Bleeding Academic Research Consortium (BARC) type 2, 3 or 5 in three groups., g) Quality of life questionnaires evaluated using SAQ 7 and SF 12., Safety of short-term use of the investigational product - assessment until 12 weeks from randomization visit based on the frequency of reported adverse events (AE, AESI, SAE) – type, grading, relationship to prasugrel /ASA.
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The assessment of the proportion of failed grafts is defined according to Fitzgibbon classification (Fitzgibbon Class B + O) 12 months after the randomization following CABG procedure in patients with DAPT with prasugrel (10mg/day) plus ASA (75mg/day) vs high-dose ASA (300mg/d) and DAPT vs low-dose ASA (75mg/day) | — |
Secondary
| Measure | Time frame |
|---|---|
| The assessment of the proportion of failed grafts defined according to Fitzgibbon classification (Fitzgibbon Class B + O) 12 months after the randomization following CABG procedure, in patients receiving high- (300mg/d) vs low-dose ASA (75mg/day)., A safety and efficacy assessment of use of the investigational products, based on the frequency of reported adverse events during the first 6 and 12 and long term follow up months after randomization., a) All-cause mortality at 12 months in the three groups, b) Incidence of myocardial infarction in the three groups, c) Incidence of stroke in the three groups, d) Incidence of repeat revascularization in the three groups, e) Incidence of MACCE (composite mortality, myocardial infarction, stroke and repeat revascularization) at 12 months and beyond 12 months in the three groups, f) Safety of treatment in terms of the incidence of bleeding within 12 months according to the Bleeding Academic Research Consortium (BARC) type 2, 3 or 5 in three grou | — |
Countries
Poland