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NCT00343395 · ClinicalTrials.gov registry record · Phase 4
Rosiglitazone and Metformin: Outcomes Trial in Nondiabetic Patients With Stable Coronary Syndromes (Romance) Pilot Study
A Phase 4 study, sponsored by Intermountain Health Care.
- Terminated
- Registry status
- Phase 4
- Development phase
- 200
- Enrollment target
NCT00343395 is a Phase 4 study that was terminated before completion, run by Intermountain Health Care. The registered enrollment target is 200 participants.
The verdict
NCT00343395, a Phase 4 study, was terminated before completion, sponsored by Intermountain Health Care.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 200 participants
- Enrollment target
Study 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 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.
Interventions
- DRUG AVANDAMET
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2006-06 |
| Est. Completion | 2008-01 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00343395
The ClinicalTrials.gov registry entry for NCT00343395 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Intermountain Health Care, which has 85 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which AVANDAMET is the first listed.
NCT00343395 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00343395 about?
NCT00343395 is a clinical study titled "Rosiglitazone and Metformin: Outcomes Trial in Nondiabetic Patients With Stable Coronary Syndromes (Romance) Pilot Study". 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...
What is the current status of trial NCT00343395?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 200 participants. The study started on 2006-06. Estimated completion is 2008-01.
What interventions are being tested in trial NCT00343395?
The interventions under investigation include: AVANDAMET (DRUG).
Who is sponsoring clinical trial NCT00343395?
This trial is sponsored by Intermountain Health Care, which has 85 total clinical trials registered on ClinicalTrials.gov.
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