Rosiglitazone and Metformin: Outcomes Trial in Nondiabetic Patients With Stable Coronary Syndromes (Romance) Pilot Study

Inclusion Criteria: The patient (male or non-pregnant female) must be > 18 years of age. The patient or legally authorized representative must sign a written informed consent, prior to the procedure, using a form that is approved by the local Institutional Review Board. Angiographically documented coronary artery disease defined as the presence of at least one 50% or greater stenosis of a major coronary artery. Stabilized post any prior ACS event (i.e., without ongoing ischemic rest pain, congestive heart failure, or malignant arrhythmias) for at least 3 months Fasting blood glucose 87-125 mg/dL Exclusion Criteria: Age <18 years Known hypersensitivity to metformin or rosiglitazone Renal insufficiency defined as calculated creatinine clearance (CrCl) <40 mL/min using the following formula: Men: CrCL (mL/min) = Weight (kg) x (140-age) 72 x serum creatinine (mg/dL) Women: 0.85 x the value calculated for men Pregnant and/or lactating women, and women of child bearing potential are excluded from this trial Co-morbidity such that the patient is not expected to survive >2 years Current therapy with rosiglitazone or metformin PCI within the previous six months (other than for the qualifying event) Prior CABG within the previous two months, scheduled CABG, or a decision to perform CABG made prior to enrollment Overt diabetes mellitus (FBG>126 or antidiabetic therapy) Any diagnosis of congestive heart failure Obstructive hepatobiliary disease or other significant hepatic disease (defined as the presence of at least one of the following: AST, ALT, GGT, total bilirubin, or alkaline phosphatase >3x upper limit normal, not related to MI Participation in any other clinical trials involving investigational or marketed products within 30 days prior to entry in the study.