CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 84 enrolled
Drug / intervention
Prasugrel +1 moredrug
Likely dose
Prasugrel 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01560780
NCT01560780Phase 3Completed
CompareCT.gov

Prasugrel for Prevention of Early Saphenous Vein Graft Thrombosis

VA Office of Research and Development·interventional·Posted Mar 22, 2012·Updated Oct 30, 2019

In Brief

A Phase 3 clinical trial evaluating Prasugrel and Placebo for Coronary Artery Bypass. Completed, enrolled 84 participants across 4 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCoronary Artery Bypass
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 22, 2012
Enrollment StartFeb 1, 2013
Primary CompletionApr 30, 2018
Study CompletionMay 31, 2018
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 14.3 years ago

Interventions

Prasugreldrug

one 10 mg tablet by mouth daily

Placebodrug

placebo similar in appearance to prasugrel