NCT07195149

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,703 (estimated)
• Sponsor: Dolnośląskie Centrum Chorób Serca im.prof. Zbigniewa Religi MEDINET Sp. z o.o. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Coronary Syndrome
• Stable Coronary Artery Disease CAD

Interventions

Type	Name	Description
DRUG	High-Dose Aspirin 300 mg	High-dose Aspirin 300 mg once daily taken orally for three months
DRUG	DAPT (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
DRUG	Low-Dose Aspirin 75 mg	Low-Dose Aspirin 75 mg once daily taken orally

Timeline

• Start date: 2025-11-25
• Primary completion: 2030-04-30
• Completion: 2030-11-30
• First posted: 2025-09-26
• Last updated: 2026-01-06

Locations

18 sites across 1 country: Poland