RecruitingPhase 3NCT07195149

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)


Sponsor

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

Enrollment

1,703 participants

Start Date

Nov 25, 2025

Study Type

INTERVENTIONAL

Conditions

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 disease undergoing coronary artery bypass grafting.


Eligibility

Min Age: 18 Years

Inclusion Criteria9

  • 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.
  • 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 Criteria20

  • 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
  • \. 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).
  • 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

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Interventions

DRUGHigh-Dose Aspirin 300 mg

High-dose Aspirin 300 mg once daily taken orally for three months

DRUGDAPT (Low-Dose Aspirin 75 mg + Prasugrel 10 mg)

Drug: Prasugrel 10 mg Prasugrel 10 mg once daily taken orally for 3 months Drug: Low-Dose Aspirin 75 mg once daily taken orally

DRUGLow-Dose Aspirin 75 mg

Low-Dose Aspirin 75 mg once daily taken orally


Locations(18)

University Clinical Hospital in Bialystok

Bialystok, Poland

Nicolaus Copernicus University Ludwik Rydygier Collegium Medicum in Bydgoszcz

Bydgoszcz, Poland

Medical University of Gdansk

Gdansk, Poland

Regional Specialist Hospital in Grudziadz

Grudziądz, Poland

Upper-Silesian Heart Center

Katowice, Poland

John Paul II Hospital

Krakow, Poland

Medical University of Lodz

Lodz, Poland

Zbigniew Religa Heart Center "Medinet"

Nowa Sól, Poland

Provincial Specialist Hospital in Olsztyn

Olsztyn, Poland

Institute of Medical Sciences in Opole

Opole, Poland

J. Struś Hospital

Poznan, Poland

Poznan University of Medical Sciences

Poznan, Poland

Pomeranian Medical University

Szczecin, Poland

Central Clinical Hospital of the Ministry of Interior and Administration

Warsaw, Poland

Medicover Hospital

Warsaw, Poland

Wroclaw Medical University

Wroclaw, Poland

Zbigniew Religa Heart Center "Medinet"

Wroclaw, Poland

Silesian Centre for Heart Diseases in Zabrze

Zabrze, Poland

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NCT07195149


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