A Multi-center Randomized Double-Blind Trial Comparing Rosiglitazone to Placebo for the Prevention of Atherosclerosis Progression after Coronary Bypass Surgery in Diabetic Patients

The primary endpoint of the study will be the change (12-month intravascular ultrasound [IVUS] – Baseline IVUS) in plaque volume in a segment of at least 40 mm in one SVG as measured by IVUS.

IVUS:
1. The change in plaque volume from baseline to 12 month follow-up in a segment of anastomosed coronary artery of at least 20 mm
2. The changes from baseline to 12-month follow-up in lumen volume and in total vessel volume in the ≥40 mm SVG segment and in the ≥20 mm coronary segment
3. The changes from baseline to 12-month follow-up in lumen area, plaque area, and total vessel area in the ≥40 mm SVG segment and in the ≥20 mm coronary segment
4. The changes from baseline to 12-month follow-up in qualitative plaque characterization in the ≥40 mm SVG segment and in the ≥20 mm coronary segment
5. The proportion of patients showing atherosclerosis changes (progression/regression)
6. The proportion of patients showing atherosclerosis changes 'concordance', i.e. progression in SVG segment and coronary segment and atherosclerosis 'discordance', i.e. progression, stabilization or regression noted in one of the analyzed segment not found in the other analyzed segment

Angiography:
1. The proportion of patients showing new occlusions in native coronary arteries or SVGs
2. The changes in reference and minimum lumen diameters of the SVG as assessed by quantitative coronary angiography (QCA)
3. The per-patient percentage of initially patent SVGs that had significant progression of atherosclerosis at the site of greatest change at follow-up

Metabolic risk factors:
Changes from baseline to 6 and 12 months of indices for comprehensive lipid, thrombosis and pro-inflammatory profiles as well as glucose-insulin homeostasis, microalbuminuria, adhesion molecules, adipokines, and other markers relevant to the evaluation and management of cardiovascular disease risk

Body composition and distribution parameters:
1. Changes in abdominal areas and volumes of adipose tissue as well as mid-thigh areas of adipose tissue and muscle attenuations assessed by computed tomography (CT) from baseline to 6 and 12 months
2. Changes in body composition assessed by DEXA from baseline to 6 and 12 months and bioelectrical impedance analysis (BIA) from baseline to 2, 4, 6 and 12 months
3. Changes in body weight, waist circumference and body mass index (BMI) will be evaluated from baseline to 2, 4, 6, 8, 10 and 12 months

Clinical outcomes:
1. The recording of clinical laboratory parameters, physical examinations, vital signs (blood pressure and heart rate), electrocardiograms, concomitant medication, and adverse events will assess patient’s safety
2. Presence of any of the following: death, myocardial infarction (MI), transient ischemic attack (TIA), stroke, hospitalization, and ischemia-driven interventions (percutaneous coronary intervention [PCI]/CABG) will be recorded
3. Fluid retention will be evaluated by BIA