Prasugrel for Prevention of Early Saphenous Vein Graft Thrombosis

• Status: Completed
• Trial end date: 2018-05-31
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized-controlled clinical trial that will randomize 120 patients undergoing clinically-indicated coronary artery bypass graft surgery to prasugrel at a dose of 10 mg daily or matching placebo for 12 months, starting at the time of hospital dismissal from surgery. The primary goal of the study is to determine whether prasugrel administration will prevent thrombus (clot) formation within a saphenous vein graft at 12 months, as examined by optical coherence tomography.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: VA Office of Research and Development
• Treatments: Prasugrel Hydrochloride

Criteria

Inclusion Criteria:

• Age 18 years or greater

• Willing and able to give informed consent. The patients must be able to comply with study procedures and follow-up.

• Undergoing clinically-indicated coronary artery bypass graft surgery

Exclusion Criteria:

• Known allergy to aspirin or prasugrel

• Need for concomitant cardiac procedure, such as valve repair or replacement

• Increased risk of bleeding, including need for warfarin or dabigatran administration

• Positive pregnancy test or breast-feeding

• Coexisting conditions that limit life expectancy to less than 12 months or that could affect a patient's compliance with the protocol

• Serum creatinine > 2.5 mg/dL

• Severe peripheral arterial disease limiting vascular access

• Prior stroke or transient ischemic attack

• Weight <60 kg or age >75 years

• Multiple distal SVG anastomoses

• Postoperative complications prolonging hospitalization