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Related trials

AAA, 2009 - aspirin vs placebo

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Primary Prevention Project, 2001 - aspirin vs no treatment

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HOT, 1998 - aspirin vs placebo

Thrombosis Prevention trial (W+A), 1998 - warfarin + aspirin vs placebo

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CAPRIE, 1996 - clopidogrel vs aspirin

Physicians Health Study, 1989 - aspirin vs placebo

British Doctor’s Trial, 1988 - aspirin vs no treatment



See also:

  • All cardiovascular prevention clinical trials
  • All clinical trials of antithrombotics
  • All clinical trials of aspirin
  •  

    Physicians Health Study study, 1989

    [NCT00000500]

    Treatments

    Studied treatment aspirin 325 mg every other day
    Control treatment placebo
    Remarks factorial design with beta caroten vs placebo

    Patients

    Patients Healthy men

    Method and design

    Randomized effectives 11037 / 11034 (studied vs. control)
    Design Parallel groups
    Blinding double blind
    Follow-up duration 60.2 months
    Primary endpoint cardiovascular mortality ?


    Results

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

    Coronary event

    163 / 11037
    266 / 11034
    0,61 [0,51;0,74]

    stroke (fatal and non fatal)

    119 / 11037
    98 / 11034
    1,21 [0,93;1,58]

    Haemmorhagic stroke

    23 / 11037
    12 / 11034
    classic 1,92 [0,95;3,85]

    Major gastrointestinal bleeding

    48 / 11037
    30 / 11034
    classic 1,60 [1,01;2,52]

    Non fatal MI

    129 / 11037
    213 / 11034
    0,61 [0,49;0,75]

    ischemic stroke

    91 / 11037
    82 / 11034
    1,11 [0,82;1,49]

    Coronary death

    34 / 11037
    53 / 11034
    0,64 [0,42;0,99]

    All cause death

    217 / 11037
    227 / 11034
    0,96 [0,79;1,15]

    Cardiovascular events

    307 / 11037
    370 / 11034
    0,83 [0,71;0,96]

    Cardiovascular death

    81 / 11037
    83 / 11034
    0,98 [0,72;1,32]

    Non fatal stroke

    110 / 11037
    92 / 11034
    1,20 [0,91;1,57]
    0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial
    Ref
    Studied treat. Control treat.
    Coronary event 163 / 11037 (1,5%) 266 / 11034 (2,4%) 0,61 [0,51;0,74]    
    stroke (fatal and non fatal) 119 / 11037 (1,1%) 98 / 11034 (0,9%) 1,21 [0,93;1,58]    
    Haemmorhagic stroke 23 / 11037 (0,2%) 12 / 11034 (0,1%) 1,92 [0,95;3,85]    
    Cardiovascular events 307 / 11037 (2,8%) 370 / 11034 (3,4%) 0,83 [0,71;0,96]    
    Non fatal MI 129 / 11037 (1,2%) 213 / 11034 (1,9%) 0,61 [0,49;0,75]    
    ischemic stroke 91 / 11037 (0,8%) 82 / 11034 (0,7%) 1,11 [0,82;1,49]    
    Coronary death 34 / 11037 (0,3%) 53 / 11034 (0,5%) 0,64 [0,42;0,99]    
    All cause death 217 / 11037 (2,0%) 227 / 11034 (2,1%) 0,96 [0,79;1,15]    
    Major gastrointestinal bleeding 48 / 11037 (0,4%) 30 / 11034 (0,3%) 1,60 [1,01;2,52]   10916 
    Cardiovascular death 81 / 11037 (0,7%) 83 / 11034 (0,8%) 0,98 [0,72;1,32]    
    Non fatal stroke 110 / 11037 (1,0%) 92 / 11034 (0,8%) 1,20 [0,91;1,57]    
    The primary endpoint (if exists) appears in blod characters
    Reference(s) used for data extraction:
  • 10916: Baigent C, Blackwell L, Collins R, Emberson J, Godwin J, Peto R, Buring J, Hennekens C, Kearney P, Meade T, Patrono C, Roncaglioni MC, Zanchetti AAspirin in the primary and secondary prevention of vascular disease: collaborative meta-analysis of individual participant data from randomised trials.Lancet 2009 May 30;373:1849-60

  • Endpoint studied treat. control treat. mean diff

    Absolute risk reduction
    Endpoint Events rate Absolute risk
    reduction (ARR)
    Studied treat. Control treat.
    Coronary event 1,48% 2,41% -9,3‰
    stroke (fatal and non fatal) 1,08% 8,88‰ 1,9‰
    Haemmorhagic stroke 2,08‰ 1,09‰ 1,0‰
    Cardiovascular events 2,78% 3,35% -5,7‰
    Non fatal MI 1,17% 1,93% -7,6‰
    ischemic stroke 8,24‰ 7,43‰ 0,8‰
    Coronary death 3,08‰ 4,80‰ -1,7‰
    All cause death 1,97% 2,06% -0,9‰
    Major gastrointestinal bleeding 4,35‰ 2,72‰ 1,6‰
    Cardiovascular death 7,34‰ 7,52‰ -0,2‰
    Non fatal stroke 9,97‰ 8,34‰ 1,6‰


    Reference(s)

    Trials register # NCT00000500
    • . Final report on the aspirin component of the ongoing Physicians' Health Study. Steering Committee of the Physicians' Health Study Research Group.. N Engl J Med 1989 Jul 20;321:129-35
      Pubmed | Hubmed | Fulltext

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