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Optimal antiplatelet therapy in patients after coronary artery bypass grafting.
EU CTIS ID: 2025-521892-30-00
What this study is testing
To compare the effect of low-dose ASA plus prasugrel with low-dose ASA and with high-dose ASA for 3 months followed by low-dose aspirin alone on graft failure in patients with stable coronary artery disease undergoing randomization following CABG procedure.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
- Operative inclusion criteria: 1. Intraoperative 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
- 2. Left anterior descending artery grafted with internal thoracic artery
You likely can't join if
- Baseline (preoperative) exclusion criteria: 1. Cardiogenic shock
- Active malignant disease or history of malignancy within the past 5 years
- Indication for DAPT (e.g. recent PCI or ACS or recent stents of peripheral arteries)
- Indication for oral anticoagulant treatment
- Indications for the use of methotrexate at a dose of 15 mg/week or more
- Any contraindication for prasugrel or ASA
See the full eligibility criteria
- 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.
- Operative inclusion criteria: 1. Intraoperative 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
- 2. Left anterior descending artery grafted with internal thoracic artery
- 3. No intraoperative decision for hybrid revascularization due to incomplete revascularization (Percutaneous coronary intervention (PCI) of the ungrafted vessel)
- 4. No endarterectomy of the grafted vessel performed
- 5. Patient did not have any additional unplanned procedure (Ex. LAAC, Ablation, valve intervention, aortic intervention)
- Baseline (preoperative) exclusion criteria: 1. Cardiogenic shock
- Active malignant disease or history of malignancy within the past 5 years
- Indication for DAPT (e.g. recent PCI or ACS or recent stents of peripheral arteries)
- Indication for oral anticoagulant treatment
- Indications for the use of methotrexate at a dose of 15 mg/week or more
- Any contraindication for prasugrel or ASA
- Planned additional cardiac or non-cardiac surgery within 12 months
- Non-cardiac co-morbidity with life expectancy less than 12 months
- History of any bleeding complications due to the use of DAPT
- History of intracranial bleeding
- History of gastro-intestinal bleeding
- Patients with recent acute coronary syndrome (ACS) (<12 months)
- Pregnancy or breastfeeding
- Lack of compliance with the use of a highly effective method of birth control
- Planned coronary endarterectomy
- Severe impaired renal function (eGFR <40ml/min/1.73 m2).
- Postoperative and prior randomization exclusion criteria: 1. Perioperative cardiogenic shock
- 2. Intraoperative death or death prior randomization
- 3. Myocardial infarction within 12-24 hours following CABG or prior randomization
- 4. Ischemic or hemorrhagic stroke within 12-24 hours following CABG or prior randomization
- 5. Any postoperative complication that may increase patients’ risk with DAPT
- 6. Atrial Fibrillation prior randomization
- Single vessel CABG
- 7. Gastro-intestinal bleeding prior randomization
- Patients with preoperative atrial fibrillation
- Dialysis
- Thrombocytopenia (platelet count < 100 000 platelets/ul)
- Anemia (Hemoglobin level < 10 g/dL)
- Severe liver failure Child-Pugh classification >4
- Known, active infections with HIV, HBV, HCV, tuberculosis
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.