Blood-thinning medicines after bypass surgery in people with stable heart disease

Trial details

Who runs it

Dolnośląskie Centrum Chorób Serca im.prof. Zbigniewa Religi MEDINET Sp. z o.o.

Trial code

NCT07195149EU 2025-521892-30-00

Record updated

27 October 2026

Original description

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.Read full original descriptionShow less

Comparing High and lOw-dose asPirin With Dual anTIplatelet Therapy for Three Months Using prasUgrel and aSpirin Following Coronary Artery Bypass Grafting. (OPTIMUS-CABG Trial)

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.

Inclusion: Baseline (preoperative) inclusion 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:; 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; Left anterior descending artery grafted with internal thoracic artery; No intraoperative decision for hybrid revascularization due to incomplete revascularization (Percutaneous coronary intervention (PCI) of the ungrafted vessel); No endarterectomy of the grafted vessel performed; Patient did not have any additional unplanned procedure (Ex. LAAC, Ablation, valve intervention, aortic intervention).

Exclusion: Postoperative and prior randomization exclusion criteria:; Intraoperative death or death prior randomization; Myocardial infarction within 12-24 hours following CABG or prior randomization; Ischemic or hemorrhagic stroke within 12-24 hours following CABG or prior randomization; Atrial Fibrillation prior randomization; Gastro-intestinal bleeding prior randomization; Patients with recent acute coronary syndrome (ACS) (<12 months); Severe liver failure Child-Pugh classification >4; Known, active infections with HIV, HBV, HCV, tuberculosis; Active malignant disease or history of malignancy within the past 5 years; Thrombocytopenia (platelet count < 100 000 platelets/uL); Anemia (Hemoglobin level < 10 g/dL); Any contraindication for prasugrel or ASA 15. Planned additional cardiac or non-cardiac surgery within 12 months 16. Non-cardiac co-morbidity with life expectancy less than 12 months 17. History of any bleeding complications due to the use of DAPT 18. History of intracranial bleeding 19. History of gastro-intestinal bleeding 20. Pregnancy or breastfeeding 21. Lack of compliance with the use of a highly effective method of birth control 22. Planned coronary endarterectomy 23. Severe impaired renal function (eGFR <40mL/min/1.73 m2); Baseline (preoperative) exclusion criteria:; Cardiogenic shock; Single vessel CABG; Patients with preoperative atrial fibrillation; Dialysis; Indication for DAPT (e.g. recent PCI or ACS or recent stents of peripheral arteries); Indication for oral anticoagulant treatment 13 Indications for the use of methotrexate at a dose of 15 mg/week or more; Perioperative cardiogenic shock; Any postoperative complication that may increase patients' risk with DAPT.

ClinicalTrials.gov NCT07195149 · EU CTIS 2025-521892-30-00