ACTIVE - W
Atrial Fibrillation Clopidogrel Trial with Irbesartan for Prevention of Vascular Events
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Status:
Trial was halted by the Data Safety Monitoring Board in September of 2005 due to evidence of benefit in favor of warfarin over clopidogrel plus aspirin therapy.
Purpose:
To determine whether clopidogrel plus aspirin therapy is as efficacious as standard warfarin therapy in preventing stroke, myocardial infarction (MI), and other vascular events in high risk patients with atrial fibrillation (AF).
Location(s):
31 countries, including: Asia and Australia, Europe, North and South America, and South Africa.
Year Started:
2003
Year Finished:
2005
Year Presented:
2005
Design:
Randomized, controlled, noninferiority trial.
Inclusion Criteria
Patients with AF plus ≥ 1 risk factor for stroke: age ≥ 75 years, hypertension, prior stroke or transient ischemic attack, left ventricular ejection fraction < 45%, peripheral arterial disease, age 55-74 years with coronary artery disease or diabetes.
Exclusion Criteria
Requirement for clopidogrel (such as recent coronary stent procedure; requirement for oral anticoagulant (such as prosthetic mechanical heart valve); prior intolerance to 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-COX-2 inhibitor NSAID therapy.
Patient Involvement:
Patients were randomized to receive either warfarin (adjusted to an international normalized ratio [INR] of 2.0-3.0, measured at least monthly) or clopidogrel 75 mg/day plus aspirin 75-100 mg/day.
Primary Outcome:
Stroke, non-central nervous system systemic embolism, MI, and vascular mortality. Safety endpoint: major bleeding.
Secondary Outcome:
Major hemorrhage, total mortality and stroke; individual components of the primary outcome and all safety criteria indluding serious adverse events.
Results:
Among these high risk patients with AF(> ¾ of whom were being treated with warfarin at the time of enrollment), clopidogrel/aspirin was inferior to warfarin, resulting in a 1.7% absolute increase (45% relative increase) in the risk of reaching the primary endpoint (5.64% vs. 3.93%, respectively; p=0.0002). The risk of major bleeding was not significantly different between the clopidogrel/aspirin and warfarin groups (2.4% vs 2.2% per year, respectively; p=0.67).
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Source of Information:
Presented at the American Heart Association (AHA) 2005 Scientific Sessions in Dallas, Texas.
Media reports.
Presented at ECS 2009 in Spain.
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Web Links and Publications:
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This information last updated on: 9/2/2009
Reviewed on: 09/02/2009.
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