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Atrial Fibrillation Clopidogrel Trial With Irbesartan for Prevention of Vascular Events (ACTIVE I)

NCT ID: NCT00249795

Last Updated: 2010-10-15

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

9016 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-06-30

Study Completion Date

2009-08-31

Brief Summary

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The purpose of this study was to determine if Irbesartan compared to Placebo would reduce the risk of vascular events such as heart attack, stroke, non-cerebral thromboembolic event and death in patients with Atrial Fibrillation (AF) and with at least one major risk of vascular events.

Detailed Description

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ACTIVE I was one of the 3 separate but related trials of the ACTIVE program conducted in AF patients at risk of vascular events.

Patients were enrolled first into one of the 2 parallel trials of the ACTIVE program evaluating Clopidogrel:

* ACTIVE A comparing clopidogrel + acetylsalicylic acid (ASA) and ASA alone
* ACTIVE W comparing clopidogrel + ASA and oral anticoagulant (OAC).

Then those satisfying additional criteria related to blood pressure and angiotensin receptor blocking agents were re-randomized in the two ACTIVE I arms according to a separate randomization list.

Conditions

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Atrial Fibrillation Cardiovascular Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Irbesartan

150 mg for 2 weeks, then up-titrated to 300 mg up to final follow-up visit

Group Type EXPERIMENTAL

Irbesartan

Intervention Type DRUG

oral administration (tablets) once daily

Placebo

Matching placebo up to final follow-up visit

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

oral administration (tablets) once daily

Interventions

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Irbesartan

oral administration (tablets) once daily

Intervention Type DRUG

placebo

oral administration (tablets) once daily

Intervention Type DRUG

Other Intervention Names

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Aprovel®

Eligibility Criteria

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Inclusion Criteria

Should fulfill the eligibility criteria for ACTIVE A or ACTIVE W trial and:

* have a systolic blood pressure of at least 110 mmHg
* not already receiving an angiotensin receptor blocking agent, unless they are willing and able to be changed to another antihypertensive agent
* no previous intolerance to angiotensin receptor blocking agents
* no proven indication for angiotensin receptor blocking agents, unless an Angiotensin Converting Enzyme (ACE) inhibitor can be substituted

Exclusion Criteria

Patients will be excluded from ACTIVE study if any of the following are present:

* requirement for clopidogrel (such as recent coronary stent procedure)
* requirement for oral anticoagulant (such as prosthetic mechanical heart valve)
* prior intolerance to acetylsalicyclic acid (ASA) or clopidogrel
* documented peptic ulcer disease within the previous 6 months
* prior intracerebral hemorrhage
* significant thrombocytopenia (platelet count \<50 x 10(9)/L)
* psychosocial reason making study participation impractical
* geographic reason making study participation impractical
* ongoing alcohol abuse
* mitral stenosis
* pregnant or nursing woman or woman of child bearing potential and not on effective birth control for at least one month prior to start of study or not willing to continue on birth control for duration of study
* severe comorbid condition such that the patient is not expected to survive 6 months
* patient currently receiving an investigational pharmacologic agent
* requirement for chronic (\> 3 months) non-cyclooxygenase-2 (non-COX-2) inhibitor nonsteroidal anti-inflammatory drug (NSAID) therapy unless willing enrolled in ACTIVE A
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role collaborator

Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

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Sanofi-aventis

Principal Investigators

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Salim YUSUF, Prof.

Role: STUDY_CHAIR

Hamilton Health Sciences Corporation

Locations

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Sanofi-Aventis Administrative Office

Bridgewater, New Jersey, United States

Site Status

Sanofi-Aventis Administrative Office

Buenos Aires, , Argentina

Site Status

Sanofi-Aventis Administrative Office

Macquarie Park, , Australia

Site Status

Sanofi-Aventis Administrative Office

Vienna, , Austria

Site Status

Sanofi-Aventis Administrative Office

Diegem, , Belgium

Site Status

Sanofi-Aventis Administrative Office

São Paulo, , Brazil

Site Status

Sanofi-Aventis Administrative Office

Laval, , Canada

Site Status

Sanofi-Aventis Administrative Office

Santiago, , Chile

Site Status

Sanofi-Aventis Administrative Office

Prague, , Czechia

Site Status

Sanofi-Aventis Administrative Office

Hørsholm, , Denmark

Site Status

Sanofi-Aventis Administrative Office

Helsinki, , Finland

Site Status

Sanofi-Aventis Administrative Office

Paris, , France

Site Status

Sanofi-Aventis Administrative Office

Berlin, , Germany

Site Status

Sanofi-Aventis Administrative Office

Athens, , Greece

Site Status

Sanofi-Aventis Administrative Office

Causeway Bay, , Hong Kong

Site Status

Sanofi-Aventis Administrative Office

Budapest, , Hungary

Site Status

Sanofi-Aventis Administrative Office

Milan, , Italy

Site Status

Sanofi-Aventis Administrative Office

Kuala Lumpur, , Malaysia

Site Status

Sanofi-Aventis Administrative Office

México, , Mexico

Site Status

Sanofi-Aventis Administrative Office

Gouda, , Netherlands

Site Status

Sanofi-Aventis Administrative Office

Lysaker, , Norway

Site Status

Sanofi-Aventis Administrative Office

Warsaw, , Poland

Site Status

Sanofi-Aventis Administrative Office

Porto Salvo, , Portugal

Site Status

Sanofi-Aventis Administrative Office

Singapore, , Singapore

Site Status

Sanofi-Aventis Administrative Office

Midrand, , South Africa

Site Status

Sanofi-Aventis Administrative Office

Barcelona, , Spain

Site Status

Sanofi-Aventis Administrative Office

Bromma, , Sweden

Site Status

Sanofi-Aventis Administrative Office

Geneva, , Switzerland

Site Status

Sanofi-Aventis Administrative Office

Taipei, , Taiwan

Site Status

Sanofi-Aventis Administrative Office

Guildford Surrey, , United Kingdom

Site Status

Countries

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United States Argentina Australia Austria Belgium Brazil Canada Chile Czechia Denmark Finland France Germany Greece Hong Kong Hungary Italy Malaysia Mexico Netherlands Norway Poland Portugal Singapore South Africa Spain Sweden Switzerland Taiwan United Kingdom

References

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ACTIVE I Investigators; Yusuf S, Healey JS, Pogue J, Chrolavicius S, Flather M, Hart RG, Hohnloser SH, Joyner CD, Pfeffer MA, Connolly SJ. Irbesartan in patients with atrial fibrillation. N Engl J Med. 2011 Mar 10;364(10):928-38. doi: 10.1056/NEJMoa1008816.

Reference Type DERIVED
PMID: 21388310 (View on PubMed)

Other Identifiers

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Clopidogrel (SR25990)

Identifier Type: -

Identifier Source: secondary_id

EFC4912 I

Identifier Type: -

Identifier Source: org_study_id