Prasugrel for Prevention of Early Saphenous Vein Graft Thrombosis

Completed · Phase 3 · Has a placebo group

Conditions studied: Coronary Artery Bypass

In brief

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.

Key facts

Study ID

NCT01560780

Run by

VA Office of Research and Development

People needed

84

Starts

2013-02-01

Expected to finish

2018-05-31

Last updated by the study team

2019-10-30

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• San Francisco VA Medical Center, San Francisco, CA — San Francisco, California, United States
• North Florida/South Georgia Veterans Health System, Gainesville, FL — Gainesville, Florida, United States
• Jesse Brown VA Medical Center Community-Based Outpatient Clinic Lake Side Divison, Chicago, IL — Chicago, Illinois, United States
• VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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