acetylsalicylic acid for Chronic coronary syndrome | Coronary artery disease

Inclusion criteria

• {"criterion_text":"- Age >18 years"}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Ability to comply with all study procedures and follow-up procedures"}
• {"criterion_text":"- Signed Informed Consent to participate in the study."}
• {"criterion_text":"- Operative inclusion criteria:  1.\tIntraoperative graft evaluation using transit time flow measurement in all grafts, normal flow in any graft is defined as mean graft flow > 15 mL/min with Pulsatility Index < 5"}
• {"criterion_text":"- 2.\tLeft anterior descending artery grafted with internal thoracic artery"}
• {"criterion_text":"- 3.\tNo intraoperative decision for hybrid revascularization due to incomplete revascularization (Percutaneous coronary intervention (PCI) of the ungrafted vessel)"}
• {"criterion_text":"- 4.\tNo endarterectomy of the grafted vessel performed"}
• {"criterion_text":"- 5.\tPatient did not have any additional unplanned procedure (Ex. LAAC, Ablation, valve intervention, aortic intervention)"}

Exclusion criteria

• {"criterion_text":"- Baseline (preoperative) exclusion criteria: 1. Cardiogenic shock"}
• {"criterion_text":"- Active malignant disease or history of malignancy within the past 5 years"}
• {"criterion_text":"- Indication for DAPT (e.g. recent PCI or ACS or recent stents of peripheral arteries)"}
• {"criterion_text":"- Indication for oral anticoagulant treatment"}
• {"criterion_text":"- Indications for the use of methotrexate at a dose of 15 mg/week or more"}
• {"criterion_text":"- Any contraindication for prasugrel or ASA"}
• {"criterion_text":"- Planned additional cardiac or non-cardiac surgery within 12 months"}
• {"criterion_text":"- Non-cardiac co-morbidity with life expectancy less than 12 months"}
• {"criterion_text":"- History of any bleeding complications due to the use of DAPT"}
• {"criterion_text":"- History of intracranial bleeding"}
• {"criterion_text":"- History of gastro-intestinal bleeding"}
• {"criterion_text":"- Patients with recent acute coronary syndrome (ACS) (<12 months)"}
• {"criterion_text":"- Pregnancy or breastfeeding"}
• {"criterion_text":"- Lack of compliance with the use of a highly effective method of birth control"}
• {"criterion_text":"- Planned coronary endarterectomy"}
• {"criterion_text":"- Severe impaired renal function (eGFR <40ml/min/1.73 m2)."}
• {"criterion_text":"- Postoperative and prior randomization exclusion criteria: 1.\tPerioperative cardiogenic shock"}
• {"criterion_text":"- 2.\tIntraoperative death or death prior randomization"}
• {"criterion_text":"- 3.\tMyocardial infarction within 12-24 hours following CABG or prior randomization"}
• {"criterion_text":"- 4.\tIschemic or hemorrhagic stroke within 12-24 hours following CABG or prior randomization"}
• {"criterion_text":"- 5.\tAny postoperative complication that may increase patients’ risk with DAPT"}
• {"criterion_text":"- 6.\tAtrial Fibrillation prior randomization"}
• {"criterion_text":"- Single vessel CABG"}
• {"criterion_text":"- 7.\tGastro-intestinal bleeding prior randomization"}
• {"criterion_text":"- Patients with preoperative atrial fibrillation"}
• {"criterion_text":"- Dialysis"}
• {"criterion_text":"- Thrombocytopenia (platelet count < 100 000 platelets/ul)"}
• {"criterion_text":"- Anemia (Hemoglobin level < 10 g/dL)"}
• {"criterion_text":"- Severe liver failure Child-Pugh classification >4"}
• {"criterion_text":"- Known, active infections with HIV, HBV, HCV, tuberculosis"}

Primary endpoints

• {"endpoint_text":"- 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)","definition_or_measurement_approach":"Failure defined according to Fitzgibbon classification (Fitzgibbon Class B + O) assessed 12 months after randomization following CABG."}

Secondary endpoints

• {"endpoint_text":"- 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).","definition_or_measurement_approach":"Fitzgibbon classification (Class B + O) at 12 months."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Frequency of reported adverse events during first 6 and 12 months and long-term follow-up after randomization."}
• {"endpoint_text":"- a) All-cause mortality at 12 months in the three groups","definition_or_measurement_approach":"All-cause mortality measured at 12 months post-randomization."}
• {"endpoint_text":"- b) Incidence of myocardial infarction in the three groups","definition_or_measurement_approach":"Incidence of myocardial infarction assessed in each group (timeframe up to 12 months and beyond as specified in objectives)."}
• {"endpoint_text":"- c) Incidence of stroke in the three groups","definition_or_measurement_approach":"Incidence of ischemic or hemorrhagic stroke assessed in each group."}
• {"endpoint_text":"- d) Incidence of repeat revascularization in the three groups","definition_or_measurement_approach":"Incidence of repeat revascularization events in each group."}
• {"endpoint_text":"- e) Incidence of MACCE (composite mortality, myocardial infarction, stroke and repeat revascularization) at 12 months and beyond 12 months in the three groups","definition_or_measurement_approach":"MACCE composite assessed at 12 months and beyond (mortality, MI, stroke, repeat revascularization)."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Incidence of bleeding events within 12 months classified by BARC types 2, 3 or 5."}
• {"endpoint_text":"- g) Quality of life questionnaires evaluated using SAQ 7 and SF 12.","definition_or_measurement_approach":"Quality of life assessed using SAQ-7 and SF-12 questionnaires at specified timepoints (6 and 12 months and long-term)."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Safety until 12 weeks from randomization based on frequency, type, grading and relationship of AEs/AESIs/SAEs to prasugrel/ASA."}

Poland

Earliest CTIS Part Ii Submission Date

13-08-2025

Latest Decision Or Authorization Date

21-11-2025

Processing Time Days

100

Number Of Sites

18

Number Of Participants

1703

Primary sponsor

Full Name

Dolnoslaskie Centrum Chorob Serca Im. Prof. Zbigniewa Religi Medinet Sp. z o.o.

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Poland

Third parties

• {"country":"Poland","full_name":"Scientia Research Institute Sp. z o.o.","duties_or_roles":"sponsorDuties codes: 1, 10, 11, 12, 14, 5, 6, 7, 8, 9","organisation_type":"Pharmaceutical company"}
• {"country":"Poland","full_name":"Komtur Polska Sp. z o.o.","duties_or_roles":"Packaging, labeling, and delivery of the IMP","organisation_type":"Pharmaceutical company"}