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)

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07195149

Acronym

OPTIMUS-CABG

Enrollment

1703

Registered

2025-09-26

Start date

2025-11-25

Completion date

2030-11-30

Last updated

2026-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Coronary Syndrome, Stable Coronary Artery Disease CAD

Keywords

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

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.

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.

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
Incidence of graft failure: DAPT vs Low-Dose Aspirin and DAPT vs High-Dose Aspirin	12 months	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)

Secondary

Measure	Time frame	Description
Key secondary outcome: Incidence of graft failure: High-Dose Aspirin vs Low-Dose Aspirin	12 months	Incidence of graft failure defined according to Fitzgibbon classification (Fitzgibbon Class B + O) 12 months after the randomization following CABG in patients with high-dose aspirin (300mg/day) vs low-dose aspirin (75mg/day)
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	Major adverse cardiac and cerebral events (MACCE) is a composite endpoint to be compared between groups defined as composite of: 1. All-cause mortality 2. Incidence of myocardial infarction 3. Incidence of stroke 4. Incidence of repeat revascularization
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	Incidence of bleeding within 12 months after randomization following CABG procedure according to the Bleeding Academic Research Consortium (BARC) type 2, 3 or 5
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	Quality of life will be assessed using quality of life questionnaires at baseline, 6 and 12 months after randomization following CABG procedure and will be evaluated using The Seattle Angina Questionnaire - 7 (SAQ-7) and Short-form-12 health survey questionnaire (SF-12)
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	Major adverse cardiac and cerebral events (MACCE) is a composite endpoint to be compared between groups defined as composite of: 1. All-cause mortality 2. Incidence of myocardial infarction 3. Incidence of stroke 4. Incidence of repeat revascularization

Countries

Poland

Contacts

CONTACTAleksandra Pawlik

badaniakliniczne@medinet.pl+48 71 320 94 50

PRINCIPAL_INVESTIGATORSleiman Sebastian Aboul-Hassan, MD, PhD

Zbigniew Religa Heart Center "Medinet"

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 15, 2026