Status:
TERMINATED
Rosiglitazone and Metformin: Outcomes Trial in Nondiabetic Patients With Stable Coronary Syndromes (Romance) Pilot Study
Lead Sponsor:
Intermountain Health Care, Inc.
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Nearly half of all Americans will die from cardiovascular disease caused by the build up of atherosclerotic plaque within coronary arteries. Most deaths in these patients arise from the development of...
Detailed Description
This is a single-center, randomized, double-blind trial comparing combined rosiglitazone/metformin (Avandametä) to placebo in subjects with normal or intermediate fasting glucose (IFG) and stable coro...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2008
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00343395
Start Date
June 1 2006
End Date
January 1 2008
Last Update
March 17 2011
Active Locations (1)
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1
Intermountain Medical Center
Murray, Utah, United States, 84157