Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00343395
Status:
TERMINATED
Last Update Posted:
2011-03-17
First Post:
2006-06-21
Brief Title:
Rosiglitazone and Metformin Outcomes Trial in Nondiabetic Patients With Stable Coronary Syndromes Romance Pilot Study
Sponsor:
Intermountain Health Care Inc
Organization:
Intermountain Health Care Inc
Study Overview
Official Title:
A Single-Center Randomized Double-Blind Placebo-Controlled Clinical Trial of Combined RosiglitazoneMetformin Avandamet vs Placebo on Serological Outcomes in Non-Diabetic Patients With Stable Coronary Syndromes
Status:
TERMINATED
Status Verified Date:
2011-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
FDA concerns regarding Avandamet
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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 ACSThe 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 rosiglitazonemetformin 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
Detailed Description:
This is a single-center randomized double-blind trial comparing combined rosiglitazonemetformin Avandametä to placebo in subjects with normal or intermediate fasting glucose IFG and stable coronary artery diseaseSubjects meeting entry criteria will be randomized in a 11 ratio to receive either placebo or combined rosiglitazonemetformin Avandametä 41000 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 rosiglitazonemetformin onsurrogate blood markers of atherosclerosis activity among non-diabetic and pre-diabetic patients with known stable coronary syndromes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None