MedTrace Logo

Prasugrel for Prevention of Early Saphenous Vein Graft Thrombosis

NCT01560780 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2019-10-30

Study results available
· View outcomes & findings →

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.

Conditions

  • Coronary Artery Bypass

Interventions

DRUG

Prasugrel

one 10 mg tablet by mouth daily

DRUG

Placebo

placebo similar in appearance to prasugrel

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Shuaib M. Abdullah, MD · VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-01
Primary Completion
2018-04-30
Completion
2018-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01560780 on ClinicalTrials.gov