Rosiglitazone and Metformin: Outcomes Trial in Nondiabetic Patients With Stable Coronary Syndromes (Romance) Pilot Study
| Status: | Archived |
|---|---|
| Conditions: | Peripheral Vascular Disease, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
A Single-Center, Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Combined Rosiglitazone/Metformin (Avandamet®) vs. Placebo on Serological Outcomes in Non-Diabetic Patients With Stable Coronary Syndromes
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.
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 coronary artery disease.Subjects meeting entry criteria
will be randomized in a 1:1 ratio to receive either placebo or combined
rosiglitazone/metformin (Avandametä) 4/1000 mg. Laboratory specimens including high
sensitivity C-reactive protein (hs-CRP), glucose, HgbA1C, complete lipid profile, will be
obtained after a 10 hour fast as specified by study visits. Subjects will return for repeat
study visits at 2, 4, 6 and 8 months for repeat laboratory evaluations, including safety
labs consisting of serum creatinine, liver enzymes, and a CBC. Additionally, subjects will
have IL-6 and TNF-a measured for research purposes at baseline and subsequent follow-up
visits. All subjects will be followed for a minimum of 8 months. This pilot study proposes
to evaluate the effect of placebo, or combined rosiglitazone/metformin onsurrogate blood
markers of atherosclerosis activity among non-diabetic and pre-diabetic patients with known
stable coronary syndromes.
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