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 | Recruiting Phase 3 DMC

• 2 other identifiers: 2024/ABM/01/000162025-521892-30-00
• Study Type: interventional
• Target: 1,703
• Locations: 1 country
• Sites: 18

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 disease undergoing coronary artery bypass grafting.

Conditions

Chronic Coronary Syndrome; Stable Coronary Artery Disease CAD

Keywords

DAPT; CABG; Prasugrel; Aspirin; CCS; Chronic coronary syndrome; Stable coronary artery disease

Outcome Measures

Primary Outcomes (1)

• Incidence of graft failure: DAPT vs Low-Dose Aspirin and DAPT vs High-Dose Aspirin

  Incidence of graft failure defined according to Fitzgibbon classification (Fitzgibbon Class B + O) 12 months after the randomization following CABG in patients with DAPT (prasugrel 10mg/day + low dose aspirin 75mg/day) versus high-dose aspirin (300mg/day) and in patients with DAPT (prasugrel 10mg/day + low dose aspirin 75mg/day) vs low-dose aspirin (75mg/day)

  12 months

Secondary Outcomes (5)

• Key secondary outcome: Incidence of graft failure: High-Dose Aspirin vs Low-Dose Aspirin

  12 months

• investigatigating the effect of DAPT versus low-dose aspirin, DAPT versus high-dose aspirin and low-dose aspirin versus high-dose aspirin on the 12-month risk of ischemic events after CABG

  12 months

• Investigatigating the effect of DAPT versus low-dose aspirin, DAPT versus high-dose aspirin and low-dose aspirin versus high-dose aspirin on the 12-month risk of bleeding events after CABG

  12 months

• Investigatigating the effect of DAPT versus low-dose aspirin, DAPT versus high-dose aspirin and low-dose aspirin versus high-dose aspirin on quality of life at 6 and 12 months after CABG.

  12 months

• investigatigating the effect of DAPT versus low-dose aspirin, DAPT versus high-dose aspirin and low-dose aspirin versus high-dose aspirin on the 60-month risk of ischemic events after CABG

  60 months

Study Arms (3)

Prasugrel 10 mg + Low Dose Aspirin 75 mg

EXPERIMENTAL

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

Low-Dose Aspirin 75 mg

ACTIVE COMPARATOR

Drug: Low-Dose Aspirin 75 mg

High-Dose Aspirin 300 mg

ACTIVE COMPARATOR

Drug: High-Dose Aspirin 300 mg

Interventions

High-Dose Aspirin 300 mg DRUG

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

High-Dose Aspirin 300 mg

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

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

Prasugrel 10 mg + Low Dose Aspirin 75 mg

Low-Dose Aspirin 75 mg DRUG

Low-Dose Aspirin 75 mg once daily taken orally

Low-Dose Aspirin 75 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Dolnośląskie Centrum Chorób Serca im.prof. Zbigniewa Religi MEDINET Sp. z o.o.: lead
• Medical Research Agency, Poland: collaborator

Study Sites (18)

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

MeSH Terms

Interventions

Aspirin; 2'-deoxythymidylyl-(3'-5')-2'-deoxyadenosine; Prasugrel Hydrochloride

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Thiophenes; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Sleiman Sebastian Aboul-Hassan, MD, PhD

  Zbigniew Religa Heart Center "Medinet"

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aleksandra Pawlik

CONTACT

+48 71 320 94 50; badaniakliniczne@medinet.pl

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator: Sleiman Sebastian Aboul-Hassan MD, PhD

Study Record Dates

• First Submitted: September 15, 2025
• First Posted: September 26, 2025
• Study Start: November 25, 2025
• Primary Completion (Estimated): April 30, 2030
• Study Completion (Estimated): November 30, 2030
• Last Updated: January 6, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

PL (18)