drugset / Trial / NCT00169832

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

NCT00169832

Phase 3 Completed 193 enrolled Laval University GlaxoSmithKline · collab
RandomizedParallel-groupQuadruple-blindPrevention

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.

Timeline

Start
2003-06
Primary completion
2007-07
Completion
2007-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Rosiglitazone Small molecule 8 mg

Indications