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Systematic review and meta-analysis

This trial is included in the following systematic reviews and meta-analyses:

atrial fibrillation - antithrombotics - primary prevention of thromboembolic events


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See also:

  • All atrial fibrillation clinical trials
  • All clinical trials of antithrombotics
  • All clinical trials of aspirin + clopidogrel
  •  
     ACTIVE A study, 2009 TRC9345 
    [NCT00249873] download pdf: aspirin + clopidogrel | antithrombotics for atrial fibrillation

    Treatments

    Studied treatment clopidogrel 75 mg daily + aspirin 75-100 mg daily
    Control treatment aspirin 75-100 mg daily alone

    Patients

    Patients Patients with AF and at least one risk factor for stroke and who are not candidates for warfarin therapy
    Inclusion criteria at least one of the following risk factors: age >75 years, hypertension, prior stroke, prior transient ischemic attack, or prior systemic embolism, left ventricular ejection fraction <45%, peripheral vascular disease, or age 54-74 years and diabetes mellitus or coronary artery disease; patient not candidates for warfarin therapy; AF documented
    Exclusion criteria excessive risk of hemorrhage; prior intracerebral hemorrhage; peptic ulcer disease; requirement for oral vitamin K antagonist or clopidogrel therapy; significant thrombocytopenia; alcohol abuse
    Baseline characteristics
    age(mean) 71 y 
    male(%) 58% 
    prior stroke(%) 13% 
    prior myocardial infarction(%) 14% 
    paroxysmal AF(%) 36% 
    heart failure(%) 33% 
    subgroup test

    Method and design

    Randomized effectives 3772 / 3782 (studied vs. control)
    Design Parallel groups
    Blinding double blind
    Follow-up duration 3.7 y
    Primary endpoint stroke, MI, systemic embolus, or vascular death


    Results



    Endpoints and data reported in the trial's publication(s)

    Endpoint Events (%) Relative Risk 95% CI
    Studied treat. Control treat.
    stroke, myocardial infarction, non–central nervous system systemic embolism, CV death 832 / 3772 (22,1%) 924 / 3782 (24,4%) 0,90 [0,83;0,98]
    Any Stroke 296 / 3772 (7,8%) 408 / 3782 (10,8%) 0,73 [0,63;0,84]
    Ischemic Stroke 235 / 3772 (6,2%) 343 / 3782 (9,1%) 0,69 [0,59;0,81]
    Hemorrhagic Stroke 30 / 3772 (0,8%) 22 / 3782 (0,6%) 1,37 [0,79;2,37]
    Stroke Of uncertain type 41 / 3772 (1,1%) 51 / 3782 (1,3%) 0,81 [0,54;1,21]
    Fatal Stroke 70 / 3772 (1,9%) 93 / 3782 (2,5%) 0,75 [0,56;1,03]
    Nondisabling Stroke 107 / 3772 (2,8%) 153 / 3782 (4,0%) 0,70 [0,55;0,89]
    Disabling or fatal Stroke 198 / 3772 (5,2%) 267 / 3782 (7,1%) 0,74 [0,62;0,89]
    Myocardial infarction 90 / 3772 (2,4%) 115 / 3782 (3,0%) 0,78 [0,60;1,03]
    Non–central nervous system systemic embolism 54 / 3772 (1,4%) 56 / 3782 (1,5%) 0,97 [0,67;1,40]
    Death from vascular causes 600 / 3772 (15,9%) 599 / 3782 (15,8%) 1,00 [0,91;1,11]
    Death from any cause 825 / 3772 (21,9%) 841 / 3782 (22,2%) 0,98 [0,90;1,07]
    Major bleeding 251 / 3772 (6,7%) 162 / 3782 (4,3%) 1,55 [1,28;1,88]
    Severe major bleeding 190 / 3772 (5,0%) 122 / 3782 (3,2%) 1,56 [1,25;1,95]
    Fatal major bleeding 42 / 3772 (1,1%) 27 / 3782 (0,7%) 1,56 [0,96;2,52]
    Minor bleeding 408 / 3772 (10,8%) 175 / 3782 (4,6%) 2,34 [1,97;2,77]
    Any bleeding 1014 / 3772 (26,9%) 651 / 3782 (17,2%) 1,56 [1,43;1,70]
    Site of major bleeding* Gastrointestinal 132 / 3772 (3,5%) 68 / 3782 (1,8%) 1,95 [1,46;2,60]
    Gastrointestinal, with transfusion 117 / 3772 (3,1%) 61 / 3782 (1,6%) 1,92 [1,42;2,61]
    Intracranial bleeding 54 / 3772 (1,4%) 29 / 3782 (0,8%) 1,87 [1,19;2,93]
    Extracranial bleeding 200 / 3772 (5,3%) 134 / 3782 (3,5%) 1,50 [1,21;1,85]

    Endpoints used by the meta-analysis and data retained for this trial

    Endpoint Studied treat.
    n/N
    Control treat.
    n/N
    Graph RR [95% CI]

    thrombo-embolic event (cerebral or systemic)

    832 / 3772
    924 / 3782
    0,90 [0,83;0,98]

    stroke (fatal and non fatal)

    296 / 3772
    408 / 3782
    0,73 [0,63;0,84]

    ischemic stroke

    235 / 3772
    343 / 3782
    0,69 [0,59;0,81]

    myocardial infarction (fatal and non fatal)

    90 / 3772
    115 / 3782
    0,78 [0,60;1,03]

    All cause death

    825 / 3772
    841 / 3782
    0,98 [0,90;1,07]

    Bleeding

    1014 / 3772
    651 / 3782
    1,56 [1,43;1,70]

    Major bleeding

    251 / 3772
    162 / 3782
    1,55 [1,28;1,88]

    Minor bleeding

    408 / 3772
    175 / 3782
    classic 2,34 [1,97;2,77]

    Haemmorhagic stroke

    30 / 3772
    22 / 3782
    classic 1,37 [0,79;2,37]

    Fatal bleeding

    42 / 3772
    27 / 3782
    classic 1,56 [0,96;2,52]

    Cardiovascular death

    600 / 3772
    599 / 3782
    1,00 [0,91;1,11]

    Fatal stroke

    70 / 3772
    93 / 3782
    0,75 [0,56;1,03]

    TE event or ischemic stroke or systemic embolism

    832 / 3772
    924 / 3782
    0,90 [0,83;0,98]

    intracranial hemorrhage

    54 / 3772
    29 / 3782
    classic 1,87 [1,19;2,93]
    0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial
    Ref
    Studied treat. Control treat.
    thrombo-embolic event (cerebral or systemic) 832 / 3772 (22,1%) 924 / 3782 (24,4%) 0,90 [0,83;0,98] stroke, myocardial infarction, non–central nervous system systemic embolism, CV death 
    stroke (fatal and non fatal) 296 / 3772 (7,8%) 408 / 3782 (10,8%) 0,73 [0,63;0,84] Any Stroke  
    ischemic stroke 235 / 3772 (6,2%) 343 / 3782 (9,1%) 0,69 [0,59;0,81] Ischemic Stroke  
    myocardial infarction (fatal and non fatal) 90 / 3772 (2,4%) 115 / 3782 (3,0%) 0,78 [0,60;1,03] Myocardial infarction 
    All cause death 825 / 3772 (21,9%) 841 / 3782 (22,2%) 0,98 [0,90;1,07] Death from any cause 
    Bleeding 1014 / 3772 (26,9%) 651 / 3782 (17,2%) 1,56 [1,43;1,70] Any bleeding 
    Major bleeding 251 / 3772 (6,7%) 162 / 3782 (4,3%) 1,55 [1,28;1,88] Major bleeding 
    Minor bleeding 408 / 3772 (10,8%) 175 / 3782 (4,6%) 2,34 [1,97;2,77] Minor bleeding 
    Haemmorhagic stroke 30 / 3772 (0,8%) 22 / 3782 (0,6%) 1,37 [0,79;2,37] Hemorrhagic Stroke  
    Fatal bleeding 42 / 3772 (1,1%) 27 / 3782 (0,7%) 1,56 [0,96;2,52] Fatal major bleeding  
    Cardiovascular death 600 / 3772 (15,9%) 599 / 3782 (15,8%) 1,00 [0,91;1,11] Death from vascular causes 
    Fatal stroke 70 / 3772 (1,9%) 93 / 3782 (2,5%) 0,75 [0,56;1,03] Fatal Stroke  
    TE event or ischemic stroke or systemic embolism 832 / 3772 (22,1%) 924 / 3782 (24,4%) 0,90 [0,83;0,98] stroke, myocardial infarction, non–central nervous system systemic embolism, CV death 
    intracranial hemorrhage 54 / 3772 (1,4%) 29 / 3782 (0,8%) 1,87 [1,19;2,93] Intracranial bleeding  
    The primary endpoint (if exists) appears in blod characters
    Reference(s) used for data extraction:
  • 0:

  • Endpoint studied treat. control treat. mean diff

    Absolute risk reduction (for a follow-up of 3.7 y)
    Endpoint Events rate Absolute risk
    reduction (ARR)
    Studied treat. Control treat.
    thrombo-embolic event (cerebral or systemic) 22,06% 24,43% -2,37%
    stroke (fatal and non fatal) 7,85% 10,79% -2,94%
    ischemic stroke 6,23% 9,07% -2,84%
    myocardial infarction (fatal and non fatal) 2,39% 3,04% -0,65%
    All cause death 21,87% 22,24% -0,37%
    Bleeding 26,88% 17,21% 9,7%
    Major bleeding 6,65% 4,28% 2,4%
    Minor bleeding 10,82% 4,63% 6,2%
    Haemmorhagic stroke 7,95‰ 5,82‰ 0,21%
    Fatal bleeding 1,11% 7,14‰ 0,40%
    Cardiovascular death 15,91% 15,84% 0,07%
    Fatal stroke 1,86% 2,46% -0,60%
    TE event or ischemic stroke or systemic embolism 22,06% 24,43% -2,37%
    intracranial hemorrhage 1,43% 7,67‰ 0,66%

    Meta-analysis of all similar trials:

    antithrombotics in atrial fibrillation for primary prevention of thromboembolic events



    Reference(s)

    TrialResults-center ID TRC9345
    Trials register # NCT00249873
    • . Effect of Clopidogrel Added to Aspirin in Patients with Atrial Fibrillation.. N Engl J Med 2009 Apr 3;:
      Pubmed | Hubmed | Fulltext

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