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AAA, 2009 - aspirin vs placebo

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See also:

  • All cardiovascular prevention clinical trials
  • All clinical trials of antiplatelets drug
  • All clinical trials of aspirin
  •  

    AAA study, 2009

    [ISRCTN66587262]

    Treatments

    Studied treatment aspirin 100mg daily
    enteric coated aspirin
    Control treatment placebo

    Patients

    Patients men and women aged 50 to 80 years with asymptomatic atherosclerosis detected by low ankle brachial index (<=0.95)
    Exclusion criteria history of MI, stroke, angina, or peripheral arterial disease; chronic liver or kidney disease; chemotherapy; contraindications to treatment with aspirin; abnormally high or low packed cell volume
    Baseline characteristics
    Age (mean), years 62y 
    Men (%) 29% 
    mean ankle brachial index 0.86 

    Method and design

    Randomized effectives 1675 / 1675 (studied vs. control)
    Design Parallel groups
    Blinding double blind
    Follow-up duration 8.2 y (mean)
    Number of centre multicenter
    Geographic area UK, Scotland
    Hypothesis Superiority
    Primary endpoint fatal or nonfatal coronary event or stroke or revascularisation


    Results



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

    Endpoint Events (%) Relative Risk 95% CI
    Studied treat. Control treat.
    fatal or nonfatal coronary event, stroke, revascularization 181 / 1675 (10,8%) 176 / 1675 (10,5%) 1,03 [0,85;1,25]
    fatal Coronary event 28 / 1675 (1,7%) 18 / 1675 (1,1%) 1,56 [0,86;2,80]
    fatal Stroke 7 / 1675 (0,4%) 12 / 1675 (0,7%) 0,58 [0,23;1,48]
    non fatal Myocardial infarction 62 / 1675 (3,7%) 68 / 1675 (4,1%) 0,91 [0,65;1,28]
    non fatal Stroke 37 / 1675 (2,2%) 38 / 1675 (2,3%) 0,97 [0,62;1,52]
    non fatal Coronary revascularization 24 / 1675 (1,4%) 20 / 1675 (1,2%) 1,20 [0,67;2,16]
    non fatal Peripheral revascularization 23 / 1675 (1,4%) 20 / 1675 (1,2%) 1,15 [0,63;2,09]
    primary end point, plus angina, intermittent claudication, and transient ischaemic 288 / 1675 (17,2%) 290 / 1675 (17,3%) 0,99 [0,86;1,15]
    Angina 72 / 1675 (4,3%) 64 / 1675 (3,8%) 1,13 [0,81;1,56]
    Intermittent claudication 53 / 1675 (3,2%) 53 / 1675 (3,2%) 1,00 [0,69;1,45]
    Transient ischemic attack 38 / 1675 (2,3%) 41 / 1675 (2,4%) 0,93 [0,60;1,43]
    Major hemorrhage 34 / 1675 (2,0%) 20 / 1675 (1,2%) 1,70 [0,98;2,94]
    Fatal Hemorrhagic stroke 3 / 1675 (0,2%) 3 / 1675 (0,2%) 1,00 [0,20;4,95]
    Nonfatal Hemorrhagic stroke 2 / 1675 (0,1%) 1 / 1675 (0,1%) 2,00 [0,18;22,04]
    Fatal Subarachnoid/subdural hemorrhage 3 / 1675 (0,2%) 0 / 1675 (0,0%) 6,00 [0,30;119,69]
    Nonfatal Subarachnoid/subdural hemorrhage 3 / 1675 (0,2%) 3 / 1675 (0,2%) 1,00 [0,20;4,95]
    Gastrointestinal hemorrhage 9 / 1675 (0,5%) 8 / 1675 (0,5%) 1,13 [0,44;2,91]
    Other hemorrhage 14 / 1675 (0,8%) 5 / 1675 (0,3%) 2,80 [1,01;7,76]
    Gastrointestinal ulcer 14 / 1675 (0,8%) 8 / 1675 (0,5%) 1,75 [0,74;4,16]
    Retinal hemorrhage 1 / 1675 (0,1%) 4 / 1675 (0,2%) 0,25 [0,03;2,23]
    Severe anemia 6 / 1675 (0,4%) 10 / 1675 (0,6%) 0,60 [0,22;1,65]

    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]

    Cardiovascular events

    181 / 1675
    176 / 1675
    1,03 [0,85;1,25]

    Major bleeding

    NA / 1675
    NA / 1675
    classic 1,71 [0,99;2,96]

    Major bleeding

    34 / 1675
    20 / 1675
    classic 1,70 [0,98;2,94]

    non fatal hemorrhagic stroke

    2 / 1675
    1 / 1675
    classic 2,00 [0,18;22,04]

    All cause death

    NA / 1675
    NA / 1675
    0,95 [0,77;1,17]

    all vascular event

    288 / 1675
    290 / 1675
    0,99 [0,86;1,15]

    fatal hemorrhagic stroke

    3 / 1675
    3 / 1675
    classic 1,00 [0,20;4,95]

    Peptic ulcer

    14 / 1675
    8 / 1675
    classic 1,75 [0,74;4,16]
    0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial
    Ref
    Studied treat. Control treat.
    Cardiovascular events 181 / 1675 (10,8%) 176 / 1675 (10,5%) 1,03 [0,85;1,25] fatal or nonfatal coronary event, stroke, revascularization   
    Major bleeding 34 / 1675 (2,0%) 20 / 1675 (1,2%) 1,70 [0,98;2,94] Major hemorrhage   
    non fatal hemorrhagic stroke 2 / 1675 (0,1%) 1 / 1675 (0,1%) 2,00 [0,18;22,04] Nonfatal Hemorrhagic stroke   
    all vascular event 288 / 1675 (17,2%) 290 / 1675 (17,3%) 0,99 [0,86;1,15] primary end point, plus angina, intermittent claudication, and transient ischaemic   
    fatal hemorrhagic stroke 3 / 1675 (0,2%) 3 / 1675 (0,2%) 1,00 [0,20;4,95] Fatal Hemorrhagic stroke   
    Peptic ulcer 14 / 1675 (0,8%) 8 / 1675 (0,5%) 1,75 [0,74;4,16] Gastrointestinal ulcer   
    The primary endpoint (if exists) appears in blod characters
    Reference(s) used for data extraction:

    Endpoint studied treat. control treat. mean diff

    Absolute risk reduction
    Endpoint Events rate Absolute risk
    reduction (ARR)
    Studied treat. Control treat.
    Cardiovascular events 10,81% 10,51% 3,0‰
    Major bleeding 2,03% 1,19% 8,4‰
    non fatal hemorrhagic stroke 1,19‰ 0,60‰ 0,6‰
    all vascular event 17,19% 17,31% -1,2‰
    fatal hemorrhagic stroke 1,79‰ 1,79‰ 0,0‰
    Peptic ulcer 8,36‰ 4,78‰ 3,6‰


    Reference(s)

    Trials register # ISRCTN66587262
    Study web site link http://www.escardio.org/congresses/esc-2009/congress-reports/Pages/706001-706002-fowkes-patrono.aspx
    • Fowkes FG, Price JF, Stewart MC, Butcher I, Leng GC, Pell AC, Sandercock PA, Fox KA, Lowe GD, Murray GD. Aspirin for prevention of cardiovascular events in a general population screened for a low ankle brachial index: a randomized controlled trial.. JAMA 2010 Mar 3;303:841-8
      Pubmed | Hubmed | Fulltext

    External links about this trial

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