ARCHIPELAGO: Irbesartan in Patients With Acute Coronary Syndrome Without ST Segment Elevation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

440 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Myocardial Ischemia Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Irbesartan

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patient hospitalised with ischemic symptoms (last episode within the last 48 hours before randomization) and at least one of the following characteristics of NSTEACS (non-ST-segment-elevation acute coronary syndromes):

* ECG ST or T changes (ST depression or transient elevation of at least 1mm or T wave changes in at least 2 leads)
* Positive troponin (according to local threshold)

Exclusion Criteria

* Women of child bearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 4 weeks after the study WOCBP using a prohibited contraceptive method (not applicable)
* Women who are pregnant or breast feeding
* Women with a positive pregnancy test on enrolment or prior to study drug administration
* Patient with dementia
* Persistent ST segment elevation at ECG
* Systolic blood pressure \< 100 mmHg
* Bilateral stenosis of renal artery
* Creatinine clearance \< or = 30ml/mn
* Congestive heart failure with symptoms consistent with New York Heart Association (NYHA) class III or IV.
* Aortic or mitral valve stenosis
* Hypertrophic cardiomyopathy
* Connective tissue disease with vascular involvement
* Angioplasty, surgery or trauma within the last 3 months
* Coronarography or angioplasty planned to be performed or performed before baseline sampling
* Febrile (≥ 38°C) disease, known concomitant viral or bacterial infection, chronic auto immune disease, chronic inflammatory disease, known cancer in evolution
* Hyperkalemia: serum potassium \> 5.5mmol/l
* Sensitivity or intolerance to Angiotensin receptor blockers (ARBs) : olmesartan, candesartan, irbesartan, eprosartan, losartan, telmisartan, valsartan and/or any other ARB currently or previously in development.
* Sensitivity or intolerance to Angiotensin-converting Enzyme Inhibitors (ACE-I) : benazepril, captopril, enalapril, lisinopril, trandolapril, ramipril, quinapril, and/or any other ACE-I currently or previously in development.
* Chronic steroid or non-steroidal anti inflammatory drugs (NSAIDs) use. Aspirin is permitted.
* Treatment with allopurinol or procaïnamide
* Concomitant use of potassium sparing diuretics (eg. spironolactone, triamterene or amiloride), potassium preparations or salt substitutes containing potassium
* Treatment with Lithium
* Immunosupressive medication
* Administration of any other investigational drug in the last 30 days before enrolment and during the course of the study
* Treatment with ARB or ACE inhibitor within the last 3 days.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No