FOCUS:Focus On Coronary Unstable Syndromes
This study has been completed.
Information provided by:
First received: December 21, 2005
Last updated: January 10, 2011
Last verified: January 2011
- To demonstrate that the acute administration of ramipril will control the inflammation process in patients with high-risk Acute Coronary Syndrome (ACS) as assessed by the high sensitivity C-reactive protein blood levels.
- To demonstrate that the normalization of blood glucose levels with intravenous insulin will improve the inflammation process during the acute phase of an ACS as assessed by Tumor necrosis factor alpha blood levels.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||A Placebo-controlled, Double-blind, Randomized, Multicenter Study of Ramipril 5 and 10 mg Capsules and Insulin Infusion in Subjects With Unstable Coronary Syndromes|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Sanofi:
Primary Outcome Measures:
- To assess the highly specific C-reactive protein (hsCRP) blood levels [ Time Frame: during the study conduct ] [ Designated as safety issue: No ]
- To assess the tumor necrosing factor alpha (TNFα) blood levels [ Time Frame: during the study conduct ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- TEAEs collection [ Time Frame: From the signature of the informed consent up to the end of the study ] [ Designated as safety issue: No ]
|Study Start Date:||June 2004|
|Primary Completion Date:||July 2005 (Final data collection date for primary outcome measure)|
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