NCT00296218

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.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
440

participants targeted

Target at P50-P75 for phase_3

Geographic Reach
11 countries

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

February 22, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 24, 2006

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
Last Updated

October 15, 2009

Status Verified

October 1, 2009

Enrollment Period

1.1 years

First QC Date

February 22, 2006

Last Update Submit

October 14, 2009

Conditions

Myocardial IschemiaHypertension

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (7)

  • 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.

  • +2 more secondary outcomes

Interventions

IrbesartanDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Sanofi-Aventis

Bridgewater, New Jersey, United States

Location

Sanofi-Aventis

Brussels, Belgium

Location

Sanofi-Aventis

Laval, Canada

Location

Sanofi-Aventis

Paris, France

Location

Sanofi-Aventis

Berlin, Germany

Location

Sanofi-Aventis

Budapest, Hungary

Location

Sanofi-Aventis

Milan, Italy

Location

Sanofi-Aventis

Gouda, Netherlands

Location

Sanofi-Aventis

Barcelona, Spain

Location

Sanofi-Aventis

Meyrin, Switzerland

Location

Sanofi-Aventis

Guildford, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 19700470RESULT

MeSH Terms

Conditions

Myocardial IschemiaHypertension

Interventions

Irbesartan

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsSpiro CompoundsTetrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPolycyclic Compounds

Study Officials

  • Catherine Domenger, MD

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 22, 2006

First Posted

February 24, 2006

Study Start

February 1, 2006

Primary Completion

March 1, 2007

Last Updated

October 15, 2009

Record last verified: 2009-10

Locations

FR(1)ES(1)US(1)GB(1)BE(1)CH(1)DE(1)NL(1)IT(1)HU(1)CA(1)