Atrial Fibrillation Clopidogrel Trial With Irbesartan for Prevention of Vascular Events (ACTIVE A)
Condition: Atrial Fibrillation; Vascular Risk
MeSH terms: Atrial Fibrillation
Intervention: clopidogrel (SR25990C); placebo
Intervention description: oral administration (tablets); oral administration (tablets)
Intervention MeSH terms: Clopidogrel
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 7554.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Atrial fibrillation; Anticoagulant therapy; Thromboembolic prevention

Summary:

      The purpose of this study is to determine if the combination of clopidogrel 75mg once daily
      (od) plus aspirin 100mg daily (recommended dose) is better than aspirin alone (100mg daily
      recommended dose) for preventing vascular events such as stroke and heart attack during
      approximately three years of follow-up in patients with atrial fibrillation associated with
      at least one major risk factor of vascular event such as elderly, blood pressure increase,
      history of stroke or transient ischemic attack or left ventricular dysfunction etc. The study
      will also accept patients with atrial fibrillation and unwilling to take oral anticoagulant
      therapy.
    

Eligibility criteria:

        Inclusion Criteria:

        To be eligible for ACTIVE A patients must have in same time the three following conditions
        :

          -  Evidence of atrial fibrillation either on one current Electrocardiogram (ECG) or two
             ECGs 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 greater;

               -  on treatment for systemic hypertension;

               -  prior stroke, Transient Ischemic Attack (TIA) or non-Central Nervous System
                  (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; f1) diabetes mellitus requiring drug therapy, or
                  f2) documented previous myocardial infarction or documented coronary artery
                  disease.

          -  To have either a contraindication to use an oral anticoagulant treatment or they are
             unwilling to take an oral anticoagulant treatment.

        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;