ARCHIPELAGO: Irbesartan in Patients With Acute Coronary Syndrome Without ST Segment Elevation
Phase 3
Completed
- Conditions
- Myocardial IschemiaHypertension
- Registration Number
- NCT00296218
- Lead Sponsor
- Sanofi
- Brief Summary
Primary Objective
* 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.
Secondary Objectives
* 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 440
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Primary Outcome Measures
Name Time Method comparison of the relative change from baseline in hsCRP at day 60 between the two treatment groups
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Sanofi-Aventis
馃嚞馃嚙Guildford, United Kingdom