ARCHIPELAGO: Irbesartan in Patients With Acute Coronary Syndrome Without ST Segment Elevation
This study has been completed.
Information provided by:
First received: February 22, 2006
Last updated: October 14, 2009
Last verified: October 2009
- The main objective of this study is to assess if a two-month regimen of irbesartan in patients hospitalized for acute coronary syndrome without ST segment elevation can reduce inflammation markers (ie hsCRP), in comparison to a similar regimen of enalapril.
- To compare both regimens on several other biological parameters which have demonstrated their relevance and their predictive clinical value (ie BNP, microalbuminuria, troponin I …) in this patient population.
- To compare on the above parameters the early initiation of treatment versus the initiation of treatment at hospital discharge.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Primary Purpose: Treatment
|Official Title:||Randomized Comparison of a Two-month Regimen of Irbesartan Versus Enalapril on Cardiovascular Markers in Patients With Acute Coronary Syndrome Without ST Segment Elevation.|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Sanofi:
Primary Outcome Measures:
- comparison of the relative change from baseline in hsCRP at day 60 between the two treatment groups
Secondary Outcome Measures:
- Relative change from baseline of hsCRP at discharge
- Changes from baseline in BNP and Microalbuminuria (MAU) at discharge and day 60
- Change of Troponin I from baseline at discharge
- In addition at baseline, discharge and D60 the following parameters will be evaluated and their evolution compared in the two treatment groups: IL6, CD 40 L, sPLA2 and Lp-PLA2, IMA, MMP-9, MPO (myeloperoxydase), aldosterone
- Blood pressure at discharge, D15 and D60.
- The early versus late (at hospital discharge) initiation of treatment will also be evaluated on the above-listed parameters.
- & Safety outcomes
|Study Start Date:||February 2006|
|Primary Completion Date:||March 2007 (Final data collection date for primary outcome measure)|
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00296218
|United States, New Jersey|
|Bridgewater, New Jersey, United States|
|Guildford, United Kingdom|
Sponsors and Collaborators
|Study Director:||Catherine Domenger, MD||Sanofi|