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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00296218
Recruitment Status : Completed
First Posted : February 24, 2006
Last Update Posted : October 15, 2009
Bristol-Myers Squibb
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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.

Condition or disease Intervention/treatment Phase
Myocardial Ischemia Hypertension Drug: Irbesartan Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 440 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double
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.
Study Start Date : February 2006
Actual Primary Completion Date : March 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Irbesartan

Primary Outcome Measures :
  1. comparison of the relative change from baseline in hsCRP at day 60 between the two treatment groups

Secondary Outcome Measures :
  1. Relative change from baseline of hsCRP at discharge
  2. Changes from baseline in BNP and Microalbuminuria (MAU) at discharge and day 60
  3. Change of Troponin I from baseline at discharge
  4. 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
  5. Blood pressure at discharge, D15 and D60.
  6. The early versus late (at hospital discharge) initiation of treatment will also be evaluated on the above-listed parameters.
  7. & Safety outcomes

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00296218

United States, New Jersey
Bridgewater, New Jersey, United States
Brussels, Belgium
Laval, Canada
Paris, France
Berlin, Germany
Budapest, Hungary
Milan, Italy
Gouda, Netherlands
Barcelona, Spain
Meyrin, Switzerland
United Kingdom
Guildford, United Kingdom
Sponsors and Collaborators
Bristol-Myers Squibb
Study Director: Catherine Domenger, MD Sanofi

Publications of Results: Identifier: NCT00296218     History of Changes
Other Study ID Numbers: PM_C_0024
EudraCT #: 2005-002161-36
First Posted: February 24, 2006    Key Record Dates
Last Update Posted: October 15, 2009
Last Verified: October 2009

Additional relevant MeSH terms:
Acute Coronary Syndrome
Myocardial Ischemia
Coronary Artery Disease
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arterial Occlusive Diseases
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action