Prasugrel for Prevention of Early Saphenous Vein Graft Thrombosis

NCT01560780 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: CLIN-007-11F
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 4

Brief 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

Keywords

Coronary Artery Bypass; thrombosis; prasugrel

Outcome Measures

Primary Outcomes (1)

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

  Number of patients with intragraft thrombus seen at 12 month follow-up by optical coherence tomography in imaged saphenous vein graft

  12 months

Secondary Outcomes (6)

• Number of Patients With Severe Bleeding Using the Global Utilization of Streptokinase and t-PA for Occluded Coronary Arteries (GUSTO) Criteria

  12 months

• Number of Patients With Angiographic Saphenous Vein Graft Failure

  12 months

• Total Target Saphenous Vein Graft Atheroma Volume, as Assessed by Intravascular Ultrasonography

  12 months

• Saphenous Vein Graft Lipid Core Burden Index, as Assessed at Near-infrared Intracoronary Spectroscopy

  12 months

• Major Adverse Cardiac Events, Defined as the Composite of Death, Acute Coronary Syndrome, or Coronary Revascularization) During Follow-up

  12 months

Study Arms (2)

Arm 1: Prasugrel

EXPERIMENTAL

prasugrel 10 mg by mouth daily

Drug: Prasugrel

Arm 2: Placebo

PLACEBO COMPARATOR

placebo by mouth once daily

Drug: Placebo

Interventions

Prasugrel DRUG

one 10 mg tablet by mouth daily

Also known as: Effient

Arm 1: Prasugrel

Placebo DRUG

placebo similar in appearance to prasugrel

Arm 2: Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (4)

San Francisco VA Medical Center, San Francisco, CA

San Francisco, California, 94121, United States

Location

North Florida/South Georgia Veterans Health System, Gainesville, FL

Gainesville, Florida, 32608, United States

Location

Jesse Brown VA Medical Center Community-Based Outpatient Clinic Lake Side Divison, Chicago, IL

Chicago, Illinois, 60611, United States

Location

VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX

Dallas, Texas, 75216, United States

Location

MeSH Terms

Conditions

Thrombosis

Interventions

Prasugrel Hydrochloride

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Shuaib Abdullah
• Organization: VA North Texas Healthcare System

shuaib.abdullah@va.gov

214-857-1458

Study Officials

• Shuaib M. Abdullah, MD

  VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2012
• First Posted: March 22, 2012
• Study Start: February 1, 2013
• Primary Completion: April 30, 2018
• Study Completion: May 31, 2018
• Last Updated: October 30, 2019
• Results First Posted: October 9, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)