Status:
RECRUITING
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)
Lead Sponsor:
Dolnośląskie Centrum Chorób Serca im.prof. Zbigniewa Religi MEDINET Sp. z o.o.
Collaborating Sponsors:
Medical Research Agency, Poland
Conditions:
Chronic Coronary Syndrome
Stable Coronary Artery Disease CAD
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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...
Detailed Description
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...
Eligibility Criteria
Inclusion
- A. 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.
- B. 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
- A. Baseline (preoperative) exclusion criteria:
- Cardiogenic shock
- Patients with recent acute coronary syndrome (ACS) (\<12 months)
- Single vessel CABG
- 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
- 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 13 Indications for the use of methotrexate at a dose of 15 mg/week or more
- 14\. 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).
- B. Postoperative and prior randomization exclusion criteria:
- Perioperative cardiogenic shock
- 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
- Any postoperative complication that may increase patients' risk with DAPT
- Atrial Fibrillation prior randomization
- Gastro-intestinal bleeding prior randomization
Key Trial Info
Start Date :
November 25 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2030
Estimated Enrollment :
1703 Patients enrolled
Trial Details
Trial ID
NCT07195149
Start Date
November 25 2025
End Date
November 30 2030
Last Update
January 6 2026
Active Locations (18)
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1
University Clinical Hospital in Bialystok
Bialystok, Poland
2
Nicolaus Copernicus University Ludwik Rydygier Collegium Medicum in Bydgoszcz
Bydgoszcz, Poland
3
Medical University of Gdansk
Gdansk, Poland
4
Regional Specialist Hospital in Grudziadz
Grudziądz, Poland