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

Information source: Sanofi
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Myocardial Ischemia; Hypertension

Intervention: Irbesartan (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Sanofi

Official(s) and/or principal investigator(s):
Catherine Domenger, MD, Study Director, Affiliation: Sanofi

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.

Clinical Details

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.

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome: comparison of the relative change from baseline in hsCRP at day 60 between the two treatment groups

Secondary outcome:

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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

The following information on clinical trials is provided for information purposes only to allow patients and physicians to have an initial discussion about the trial. This information is not intended to be complete information about the trial, to contain all considerations that may be relevant to potential participation in the trial, or to replace the advice of a personal physician or health professional. Main criteria are listed hereafter: 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.

Locations and Contacts

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

Sanofi-Aventis, Guildford, United Kingdom

Sanofi-Aventis, Bridgewater, New Jersey, United States

Additional Information

Starting date: February 2006
Last updated: October 14, 2009

Page last updated: August 23, 2015

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