Vein-Coronary Atherosclerosis And Rosiglitazone After Bypass Surgery: The VICTORY Trial
Condition: Diabetes; Coronary Artery Bypass Grafting
MeSH terms: Atherosclerosis
Study type: Interventional
Phase: Phase 3

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.
    

Detailed description: 
      STUDY DESIGN

      This is a prospective multicenter randomized placebo-controlled double-blind trial assessing
      the efficacy and safety of rosiglitazone in the prevention of atherosclerosis progression in
      vein grafts and native coronary arteries of diabetic patients. Stable diabetic patients with
      previous coronary bypass surgery (≥ 1 year ≤ 10 years) will be screened. After baseline
      evaluation, all eligible patients will undergo baseline coronary angiogram. IVUS will be
      performed in a segment length of at least 40 mm in a SVG suitable for IVUS analysis and in a
      segment length of at least 20 mm in the anastomosed native coronary artery corresponding to
      the SVG chosen. Following the IVUS procedure, patients will be randomized to either
      rosiglitazone treatment or to placebo in addition to their standard clinical care. Study drug
      will be titrated over an 8-week period up to a dose of 8 mg/day (or to maximum tolerated
      dose). The patients will receive the study drug or the placebo for 50-54 weeks in a
      double-blind manner. At the beginning and at 2, 4, 6, 8, 10 and 12 months of treatment,
      patients will be subjected to a set of morphological, physiological and metabolic
      evaluations. At the final visit (12 months), patients will also be submitted to IVUS and
      angiography.
    

Intervention name(s): Rosiglitazone or placebo
Intervention type(s): Drug
Intervention description(s): Rosiglitazone 4 to 8 mg/day or placebo, for 12 months
Other intervention name(s): Avandia
Intervention MeSH terms: Rosiglitazone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Atherosclerosis progression; Ischemic heart disease; Saphenous vein graft; Metabolic risk factors; Rosiglitazone