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Vein-Coronary Atherosclerosis And Rosiglitazone After Bypass Surgery: The VICTORY Trial

NCT00169832 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 193

Last updated 2008-10-10

No results posted yet for this study

Summary

HYPOTHESES

* Rosiglitazone in diabetic patients with previous coronary bypass surgery may prevent or slow the progression of atherosclerosis in SVGs and native coronary arteries.
* Rosiglitazone has favorable effects on adipose tissue distribution variables as well as on thrombosis, pro-inflammatory, and lipid profiles in diabetic patients after coronary bypass artery surgery.
* Rosiglitazone therapy influences favorably metabolism and clinical outcomes in diabetic patients after coronary artery bypass surgery.

OBJECTIVES

* PRIMARY To assess the efficacy of rosiglitazone to reduce atherosclerosis progression in vein grafts in diabetic patients after coronary bypass surgery by using IVUS imaging after a 12 mo follow-up.
* SECONDARY

* To prospectively compare the secondary IVUS endpoints.
* To prospectively compare the angiographic endpoints.
* To prospectively compare the metabolic risk factor endpoints.
* To prospectively compare the body composition and distribution endpoints.
* To prospectively compare the clinical outcomes of rosiglitazone versus standard care using composite endpoints.

Conditions

  • Diabetes
  • Coronary Artery Bypass Grafting

Interventions

DRUG

Rosiglitazone or placebo

Rosiglitazone 4 to 8 mg/day or placebo, for 12 months

Sponsors & Collaborators

Principal Investigators

  • Olivier F Bertrand, MD, PhD · Laval Hospital Research Center

  • Jean-Pierre Despres, PhD · Laval Hospital Research Center

  • Paul Poirier, MD, PhD · Laval Hospital Research Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2003-06-30
Primary Completion
2007-07-31
Completion
2007-07-31

Countries

  • Canada
  • Spain

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT00169832 on ClinicalTrials.gov