CompletedPhase 3

Prasugrel for Prevention of Early Saphenous Vein Graft Thrombosis

United States84 participantsStarted 2013-02-01

Plain-language 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.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Prevalence of Intragraft Thrombus at 12-month Follow-up Optical Coherence Tomography Imaging

Timeframe: 12 months

Trial details

NCT IDNCT01560780

SponsorVA Office of Research and Development

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2018-04-30

Results submitted2019-05-22

View on ClinicalTrials.gov More Coronary Artery Bypass trials