Phase 3 N=84 Randomized Quadruple-blind Treatment

Prasugrel for Prevention of Early Saphenous Vein Graft Thrombosis

Coronary Artery Bypass

Bottom Line

View on ClinicalTrials.gov: NCT01560780 ↗

Enrolled (actual)

Serious AEs

15.5%

Results posted

Oct 2019

Primary outcome: Primary: Prevalence of Intragraft Thrombus at 12-month Follow-up Optical Coherence Tomography Imaging — 14; 14 Participants — p=0.78

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Prasugrel (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: VA Office of Research and Development
Primary completion: Apr 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Prevalence of Intragraft Thrombus at 12-month Follow-up Optical Coherence Tomography Imaging	14; 14	0.78
SECONDARY Number of Patients With Severe Bleeding Using the Global Utilization of Streptokinase and t-PA for Occluded Coronary Arteries (GUSTO) Criteria	1; 0	>0.99
SECONDARY Number of Patients With Angiographic Saphenous Vein Graft Failure	7; 12	0.19
SECONDARY Total Target Saphenous Vein Graft Atheroma Volume, as Assessed by Intravascular Ultrasonography	349; 358	0.85
SECONDARY Saphenous Vein Graft Lipid Core Burden Index, as Assessed at Near-infrared Intracoronary Spectroscopy	7.5; 7.4	0.97
SECONDARY Major Adverse Cardiac Events, Defined as the Composite of Death, Acute Coronary Syndrome, or Coronary Revascularization) During Follow-up	8; 4	—
SECONDARY Normalized Total Target Saphenous Vein Graft Atheroma Volume, as Assessed by Intravascular Ultrasonography	0.093; 0.079	0.97

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.

Eligibility 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 75 years
Multiple distal SVG anastomoses
Postoperative complications prolonging hospitalization

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01560780). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.