High- vs low-dose aspirin and aspirin plus prasugrel after coronary artery bypass grafting

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)

This trial will test whether adding prasugrel to low-dose aspirin or using high-dose aspirin works better than low-dose aspirin alone to prevent graft failure in adults with stable coronary artery disease after coronary bypass surgery.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1703 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Dolnośląskie Centrum Chorób Serca im.prof. Zbigniewa Religi MEDINET Sp. z o.o. (Academic / other)
• Drugs / interventions: methotrexate
• Locations: 18 sites (Bialystok and 17 other locations)
• Trial ID: NCT07195149 on ClinicalTrials.gov

What this trial studies

This is a multicenter, randomized, three-arm Phase 3 trial comparing low-dose aspirin plus prasugrel versus low-dose aspirin alone versus high-dose aspirin for the first three months after primary isolated coronary artery bypass grafting, followed by low-dose aspirin up to 12 months. Eligible patients are adults with chronic coronary syndrome undergoing CABG with at least two grafts and meeting predefined intraoperative graft flow criteria. The primary outcome is graft failure at 12 months, with clinical follow-up and imaging-based assessment of graft patency. The trial is conducted at multiple university hospitals in Poland.

Who should consider this trial

Good fit: Adults with stable coronary artery disease scheduled for primary isolated CABG with at least two grafts who can comply with study procedures and give informed consent are ideal candidates.

Not a fit: Patients with acute coronary syndromes, those requiring hybrid revascularization, those who cannot take prasugrel or aspirin, or who fail the intraoperative graft flow criteria are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the regimen could lower graft failure rates and improve long-term outcomes after CABG.

How similar studies have performed: Previous trials of dual antiplatelet therapy after CABG have shown mixed results and the specific use of prasugrel in this setting is less well studied.

Eligibility criteria

Inclusion Criteria:

A. Baseline (preoperative) inclusion criteria

1. Age \>18 years
2. 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.
3. Ability to comply with all study procedures and follow-up procedures
4. Signed Informed Consent to participate in the study.

B. 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)

Exclusion Criteria:

A. Baseline (preoperative) exclusion criteria:

1. Cardiogenic shock
2. Patients with recent acute coronary syndrome (ACS) (\<12 months)
3. Single vessel CABG
4. Patients with preoperative atrial fibrillation
5. Dialysis
6. Thrombocytopenia (platelet count \< 100 000 platelets/uL)
7. Anemia (Hemoglobin level \< 10 g/dL)
8. Severe liver failure Child-Pugh classification \>4
9. Known, active infections with HIV, HBV, HCV, tuberculosis
10. Active malignant disease or history of malignancy within the past 5 years
11. Indication for DAPT (e.g. recent PCI or ACS or recent stents of peripheral arteries)
12. 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:

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
7. Gastro-intestinal bleeding prior randomization

Where this trial is running

Bialystok and 17 other locations

• University Clinical Hospital in Bialystok — Bialystok, Poland (Not_yet_recruiting)
• Nicolaus Copernicus University Ludwik Rydygier Collegium Medicum in Bydgoszcz — Bydgoszcz, Poland (Not_yet_recruiting)
• Medical University of Gdansk — Gdansk, Poland (Not_yet_recruiting)
• Regional Specialist Hospital in Grudziadz — Grudziądz, Poland (Not_yet_recruiting)
• Upper-Silesian Heart Center — Katowice, Poland (Not_yet_recruiting)
• John Paul II Hospital — Krakow, Poland (Not_yet_recruiting)
• Medical University of Lodz — Lodz, Poland (Not_yet_recruiting)
• Zbigniew Religa Heart Center "Medinet" — Nowa Sól, Poland (Recruiting)
• Provincial Specialist Hospital in Olsztyn — Olsztyn, Poland (Not_yet_recruiting)
• Institute of Medical Sciences in Opole — Opole, Poland (Not_yet_recruiting)
• J. Struś Hospital — Poznan, Poland (Not_yet_recruiting)
• Poznan University of Medical Sciences — Poznan, Poland (Not_yet_recruiting)
• Pomeranian Medical University — Szczecin, Poland (Not_yet_recruiting)
• Central Clinical Hospital of the Ministry of Interior and Administration — Warsaw, Poland (Not_yet_recruiting)
• Medicover Hospital — Warsaw, Poland (Not_yet_recruiting)
• Wroclaw Medical University — Wroclaw, Poland (Not_yet_recruiting)
• Zbigniew Religa Heart Center "Medinet" — Wroclaw, Poland (Recruiting)
• Silesian Centre for Heart Diseases in Zabrze — Zabrze, Poland (Not_yet_recruiting)

Study contacts

• Principal investigator: Sleiman Sebastian Aboul-Hassan, MD, PhD — Zbigniew Religa Heart Center "Medinet"
• Study coordinator: Aleksandra Pawlik

Conditions Chronic Coronary Syndrome; Stable Coronary Artery Disease CAD; DAPT; CABG; Prasugrel; Aspirin; CCS; Chronic coronary syndrome