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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) | Clinical Trials | Clareo Health

RECRUITINGPHASE3

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)

NCT07195149•Dolnośląskie Centrum Chorób Serca im.prof. Zbigniewa Religi MEDINET Sp. z o.o.

View on ClinicalTrials.gov

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.

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 failure at 12 months in patients with stable coronary artery disease (chronic coronary syndrome) following a coronary artery bypass grafting.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
•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

•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
+10 more criteria

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

Key Dates

Start Date

November 25, 2025

Primary Completion Date

April 30, 2030

Completion Date

November 30, 2030

Last Updated

January 6, 2026

Enrollment

1,703

ESTIMATED participants

Conditions

Chronic Coronary SyndromeStable Coronary Artery Disease CAD

Interventions

High-Dose Aspirin 300 mg

DRUG

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

DRUG

Low-Dose Aspirin 75 mg

DRUG

Contacts

Aleksandra Pawlik

CONTACT

+48 71 320 94 50 badaniakliniczne@medinet.pl

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 6, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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)

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