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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
440
Sanofi-Aventis
Bridgewater, New Jersey, United States
Sanofi-Aventis
Brussels, Belgium
Sanofi-Aventis
Laval, Canada
Sanofi-Aventis
Paris, France
Sanofi-Aventis
Berlin, Germany
Sanofi-Aventis
Budapest, Hungary
Sanofi-Aventis
Milan, Italy
Sanofi-Aventis
Gouda, Netherlands
Sanofi-Aventis
Barcelona, Spain
Sanofi-Aventis
Meyrin, Switzerland
...and 1 more locations
comparison of the relative change from baseline in hsCRP at day 60 between the two treatment groups
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
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