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
Information provided by:

February 22, 2006
February 24, 2006
October 15, 2009
February 2006
March 2007   (Final data collection date for primary outcome measure)
comparison of the relative change from baseline in hsCRP at day 60 between the two treatment groups
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Complete list of historical versions of study NCT00296218 on Archive Site
  • 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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ARCHIPELAGO: Irbesartan in Patients With Acute Coronary Syndrome Without ST Segment Elevation
Randomized Comparison of a Two-month Regimen of Irbesartan Versus Enalapril on Cardiovascular Markers in Patients With Acute Coronary Syndrome Without ST Segment Elevation.

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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Phase 3
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double
Primary Purpose: Treatment
  • Myocardial Ischemia
  • Hypertension
Drug: Irbesartan
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Montalescot G, Drexler H, Gallo R, Pearson T, Thoenes M, Bhatt DL. Effect of irbesartan and enalapril in non-ST elevation acute coronary syndrome: results of the randomized, double-blind ARCHIPELAGO study. Eur Heart J. 2009 Nov;30(22):2733-41. doi: 10.1093/eurheartj/ehp301. Epub 2009 Aug 21.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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March 2007   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Belgium,   Canada,   France,   Germany,   Hungary,   Italy,   Netherlands,   Spain,   Switzerland,   United Kingdom,   United States
EudraCT #: 2005-002161-36
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Bristol-Myers Squibb
Study Director: Catherine Domenger, MD Sanofi
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP