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)

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorDolnośląskie Centrum Chorób Serca im.prof. Zbigniewa Religi MEDINET Sp. z o.o.

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

Cardiogenic shock

Patients with recent acute coronary syndrome (ACS) (<12 months)

Single vessel CABG

Patients with preoperative atrial fibrillation

Trial design

Treatments tested in this trial

  • High-Dose Aspirin 300 mg
  • DAPT (Low-Dose Aspirin 75 mg + Prasugrel 10 mg)
  • Low-Dose Aspirin 75 mg

Treatment groups

1,703 Participants
are divided into 3 treatment groups

Sponsors and collaborators