Status:
TERMINATED
Atrial Fibrillation Clopidogrel Trial With Irbesartan for Prevention of Vascular Events (ACTIVE W)
Lead Sponsor:
Sanofi
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Atrial Fibrillation
Vascular Risk
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine if the combination of Clopidogrel 75mg once daily (od) plus aspirin at 100mg daily (recommended dose) is as effective as oral anticoagulation therapy with a l...
Eligibility Criteria
Inclusion
- Evidence of atrial fibrillation either on one current Electrocardiogram (ECG) or on two ECG recorded at two weeks a part during 6 months prior to study enrollment.
- Evidence of high risk of vascular events: at least one of the following risk criteria must be present:
- are 75 years or greater;
- on treatment for systemic hypertension;
- prior stroke, TIA, or non-CNS systemic embolus;
- left ventricular dysfunction with left ventricular ejection fraction (EF) estimated by echocardiogram or angiogram (radionuclide or contrast) to be \< 45%;
- peripheral vascular disease (previous peripheral artery revascularization, limb and foot amputation, or the combination of current intermittent claudication and ankle arm systolic blood pressure ratio \< 0.9);
- age 55 to 74 years; AND
- either diabetes mellitus requiring drug therapy, or documented previous myocardial infarction, or documented coronary artery disease.
Exclusion
- Patients will be excluded from ACTIVE 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 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; OR
- requirement for chronic (\> 3 months) non-COX-2 inhibitor NSAID therapy.
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2005
Estimated Enrollment :
6706 Patients enrolled
Trial Details
Trial ID
NCT00243178
Start Date
July 1 2003
End Date
September 1 2005
Last Update
October 19 2009
Active Locations (32)
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1
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
2
Sanofi-Aventis Administrative Office
Macquarie Park, Australia
3
Sanofi-Aventis Administrative Office
Vienna, Austria
4
Sanofi-Aventis Administrative Office
Diegem, Belgium