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
Location: See all (18) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ A. Baseline (preoperative) inclusion criteria

• 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.

⁃ B. Operative inclusion criteria:

• 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)

Locations
Other Locations
Poland
University Clinical Hospital in Bialystok
NOT_YET_RECRUITING
Bialystok
Nicolaus Copernicus University Ludwik Rydygier Collegium Medicum in Bydgoszcz
NOT_YET_RECRUITING
Bydgoszcz
Medical University of Gdansk
NOT_YET_RECRUITING
Gdansk
Regional Specialist Hospital in Grudziadz
NOT_YET_RECRUITING
Grudziądz
Upper-Silesian Heart Center
NOT_YET_RECRUITING
Katowice
John Paul II Hospital
NOT_YET_RECRUITING
Krakow
Medical University of Lodz
NOT_YET_RECRUITING
Lodz
Zbigniew Religa Heart Center Medinet
RECRUITING
Nowa Sól
Provincial Specialist Hospital in Olsztyn
NOT_YET_RECRUITING
Olsztyn
Institute of Medical Sciences in Opole
NOT_YET_RECRUITING
Opole
J. Struś Hospital
NOT_YET_RECRUITING
Poznan
Poznan University of Medical Sciences
NOT_YET_RECRUITING
Poznan
Pomeranian Medical University
NOT_YET_RECRUITING
Szczecin
Central Clinical Hospital of the Ministry of Interior and Administration
NOT_YET_RECRUITING
Warsaw
Medicover Hospital
NOT_YET_RECRUITING
Warsaw
Wroclaw Medical University
NOT_YET_RECRUITING
Wroclaw
Zbigniew Religa Heart Center Medinet
NOT_YET_RECRUITING
Wroclaw
Silesian Centre for Heart Diseases in Zabrze
NOT_YET_RECRUITING
Zabrze
Contact Information
Primary
Aleksandra Pawlik
badaniakliniczne@medinet.pl
+48 71 320 94 50
Time Frame
Start Date: 2025-11-25
Estimated Completion Date: 2030-11-30
Participants
Target number of participants: 1703
Treatments
Experimental: Prasugrel 10 mg + Low Dose Aspirin 75 mg
Active_comparator: Low-Dose Aspirin 75 mg
Active_comparator: High-Dose Aspirin 300 mg
Sponsors
Collaborators: Medical Research Agency, Poland
Leads: Dolnośląskie Centrum Chorób Serca im.prof. Zbigniewa Religi MEDINET Sp. z o.o.

This content was sourced from clinicaltrials.gov