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

Primary Purpose

Myocardial Ischemia, Hypertension

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Irbesartan
Sponsored by
Sanofi
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Ischemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sanofi-Aventis
  • Sanofi-Aventis
  • Sanofi-Aventis
  • Sanofi-Aventis
  • Sanofi-Aventis
  • Sanofi-Aventis
  • Sanofi-Aventis
  • Sanofi-Aventis
  • Sanofi-Aventis
  • Sanofi-Aventis
  • Sanofi-Aventis

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
February 22, 2006
Last Updated
October 14, 2009
Sponsor
Sanofi
Collaborators
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT00296218
Brief Title
ARCHIPELAGO: Irbesartan in Patients With Acute Coronary Syndrome Without ST Segment Elevation
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 Type
Interventional

2. Study Status

Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Sanofi
Collaborators
Bristol-Myers Squibb

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Ischemia, Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
Double
Allocation
Randomized
Enrollment
440 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Irbesartan
Primary Outcome Measure Information:
Title
comparison of the relative change from baseline in hsCRP at day 60 between the two treatment groups
Secondary Outcome Measure Information:
Title
Relative change from baseline of hsCRP at discharge
Title
Changes from baseline in BNP and Microalbuminuria (MAU) at discharge and day 60
Title
Change of Troponin I from baseline at discharge
Title
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
Title
Blood pressure at discharge, D15 and D60.
Title
The early versus late (at hospital discharge) initiation of treatment will also be evaluated on the above-listed parameters.
Title
& Safety outcomes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine Domenger, MD
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis
City
Bridgewater
State/Province
New Jersey
Country
United States
Facility Name
Sanofi-Aventis
City
Brussels
Country
Belgium
Facility Name
Sanofi-Aventis
City
Laval
Country
Canada
Facility Name
Sanofi-Aventis
City
Paris
Country
France
Facility Name
Sanofi-Aventis
City
Berlin
Country
Germany
Facility Name
Sanofi-Aventis
City
Budapest
Country
Hungary
Facility Name
Sanofi-Aventis
City
Milan
Country
Italy
Facility Name
Sanofi-Aventis
City
Gouda
Country
Netherlands
Facility Name
Sanofi-Aventis
City
Barcelona
Country
Spain
Facility Name
Sanofi-Aventis
City
Meyrin
Country
Switzerland
Facility Name
Sanofi-Aventis
City
Guildford
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
19700470
Citation
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.
Results Reference
result

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

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