Status:
COMPLETED
Atrial Fibrillation Clopidogrel Trial With Irbesartan for Prevention of Vascular Events (ACTIVE I)
Lead Sponsor:
Sanofi
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Atrial Fibrillation
Cardiovascular Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 patie...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
9016 Patients enrolled
Trial Details
Trial ID
NCT00249795
Start Date
June 1 2003
End Date
August 1 2009
Last Update
October 15 2010
Active Locations (30)
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1
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
2
Sanofi-Aventis Administrative Office
Buenos Aires, Argentina
3
Sanofi-Aventis Administrative Office
Macquarie Park, Australia
4
Sanofi-Aventis Administrative Office
Vienna, Austria