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

This study has been terminated.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00243178
First received: October 20, 2005
Last updated: October 16, 2009
Last verified: October 2009
History of Changes

October 20, 2005
October 16, 2009
July 2003
September 2005   (final data collection date for primary outcome measure)
Primary outcome:time to the first occurrence of stroke, non-CNS systemic embolism, myocardial infarction or vascular death [ Time Frame: during approximately three years of follow-up ] [ Designated as safety issue: No ]
The primary outcome will be the time to the first occurrence of stroke, non-CNS systemic embolism, myocardial infarction or vascular death during approximately three years of follow-up.
Complete list of historical versions of study NCT00243178 on ClinicalTrials.gov Archive Site
Secondary outcomes: major hemorrhage, total mortality and stroke. [ Time Frame: during approximately three years of follow-up ] [ Designated as safety issue: Yes ]
  • The secondary outcomes will be :
  • - Major hemorrhage, total mortality and stroke.The other outcomes will include individual components of the primary outcome and all safety criteria including serious adverse events.
Not Provided
Not Provided
 
Atrial Fibrillation Clopidogrel Trial With Irbesartan for Prevention of Vascular Events (ACTIVE W)
A Parallel Randomized Controlled Evaluation of Clopidogrel Plus Aspirin, With Factorial Evaluation of Irbesartan, for the Prevention of Vascular Events, in Patients With Atrial Fibrillation

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 lower risk of bleeding in patients with atrial fibrillation associated with at least one major cardiovascular risk factor.Primary objectives :The combination of clopidogrel plus aspirin compared to adjusted dose (INR between 2.0 and 3.3) oral anticoagulation (a vitamin K antagonist) will result in the same risk of the composite outcome of stroke, non-CNS systemic embolism, myocardial infarction or vascular death in patients with atrial fibrillation.The secondary objective is to establish whether or not aspirin plus clopidogrel has a lower risk of hemorrhage than standard anticoagulation therapy.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Atrial Fibrillation
  • Vascular Risk
Drug: clopidogrel (SR25990C)
75 mg once daily in combination with aspirin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
6706
September 2005
September 2005   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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 Criteria:

  • 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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Austria,   Belgium,   Brazil,   Canada,   Chile,   Czech Republic,   Denmark,   Finland,   France,   Germany,   Greece,   Hong Kong,   Hungary,   Israel,   Italy,   Malaysia,   Mexico,   Netherlands,   Norway,   Poland,   Portugal,   Russian Federation,   Singapore,   South Africa,   Spain,   Sweden,   Switzerland,   Taiwan,   Turkey,   United Kingdom
 
NCT00243178
EFC4912 W
Not Provided
ICD Study Director, Sanofi-aventis
Sanofi
Bristol-Myers Squibb
Study Chair: Salim YUSUF, Prof. Hamilton Health Sciences Corporation
Sanofi
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP