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

Stopped early · Phase 4 · Has a placebo group

Conditions studied: Coronary Artery Disease

In brief

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 acute coronary syndromes (ACS) such as myocardial infarction, unstable angina, or sudden death. ACS is characterized by coronary plaque erosion or rupture, which is triggered by endothelial changes, including inflammation, and thrombosis. Diabetes, with insulin resistance as a major component, has been shown to engender adverse metabolic events within the endothelial cell \[1\], including impaired endothelial function, augmented vasoconstriction, increased inflammation and thrombosis. Activation of the transcription factors nuclear factor KB (NF-KB) and activator protein 1 (AP-1) induces inflammatory gene expression, with liberation of leukocyte-attracting chemokines, increased production of inflammatory cytokines, and augmented expression of cellular adhesion molecules. These metabolic processes may therefore play a significant role in the development of ACS.The hypothesis is that rosiglitazone and metformin, or the combination of both may provide positive anti-atherogenic effect, even among patients without diabetes. This pilot study proposes to evaluate the effect of placebo vs. combined rosiglitazone/metformin (Avandamet®) on surrogate blood markers of atherosclerosis activity among non-diabetic and pre-diabetic patients with known stable coronary syndromes. This will provide further evidence justifying a large definitive outcomes-based clinical trial.

Key facts

Study ID: NCT00343395
Run by: Intermountain Health Care, Inc.
People needed: 200
Starts: 2006-06-01
Expected to finish: 2008-01-01
Last updated by the study team: 2011-03-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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.

Where it is running

Intermountain Medical Center — Murray, Utah, United States

Full record on ClinicalTrials.gov

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