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See also:

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

    Thrombosis Prevention Trial study, 1998

    [NCT00000614]

    Treatments

    Studied treatment aspirin 75 mg/d (controlled release)
    Control treatment placebo
    Remarks factorial design: warafrin vs placebo

    Patients

    Patients Men at high risk of CHD
    Baseline characteristics
    Age (yr) 57y 
    Body-mass index 27.5 

    Method and design

    Randomized effectives 2545 / 2540 (studied vs. control)
    Design Factorial plan
    Blinding double blind
    Follow-up duration median 6.8y
    Number of centre 108
    Geographic area UK
    Hypothesis Superiority
    Primary endpoint ischemic heart diseases


    Results

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

    Coronary event

    83 / 2545
         107 / 2540
         0,77 [0,58;1,03]

    stroke (fatal and non fatal)

    18 / 2545
         26 / 2540
         0,69 [0,38;1,26]

    Haemmorhagic stroke

    12 / 2545
         6 / 2540
         classic 2,00 [0,75;5,31]

    Major gastrointestinal bleeding

    20 / 2545
         13 / 2540
         classic 1,54 [0,77;3,08]

    Non fatal MI

    94 / 2545
         137 / 2540
         0,68 [0,53;0,89]

    ischemic stroke

    21 / 2545
         33 / 2540
         0,64 [0,37;1,09]

    Coronary death

    36 / 2545
         34 / 2540
         1,06 [0,66;1,68]

    All cause death

    113 / 2545
         110 / 2540
         1,03 [0,79;1,33]

    Cardiovascular events

    228 / 2545
         260 / 2540
         0,88 [0,74;1,04]

    Cardiovascular death

    101 / 2545
         81 / 2540
         1,24 [0,93;1,66]

    Non fatal stroke

    33 / 2545
         42 / 2540
         0,78 [0,50;1,23]     0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial    		 Ref
    Studied treat. Control treat.
    Coronary event 83 / 2545 (3,3%) 107 / 2540 (4,2%) 0,77 [0,58;1,03]    
    stroke (fatal and non fatal) 18 / 2545 (0,7%) 26 / 2540 (1,0%) 0,69 [0,38;1,26]    
    Haemmorhagic stroke 12 / 2545 (0,5%) 6 / 2540 (0,2%) 2,00 [0,75;5,31]    
    Cardiovascular events 228 / 2545 (9,0%) 260 / 2540 (10,2%) 0,88 [0,74;1,04]    
    Non fatal MI 94 / 2545 (3,7%) 137 / 2540 (5,4%) 0,68 [0,53;0,89]    
    ischemic stroke 21 / 2545 (0,8%) 33 / 2540 (1,3%) 0,64 [0,37;1,09]    
    Coronary death 36 / 2545 (1,4%) 34 / 2540 (1,3%) 1,06 [0,66;1,68]    
    All cause death 113 / 2545 (4,4%) 110 / 2540 (4,3%) 1,03 [0,79;1,33]    
    Major gastrointestinal bleeding 20 / 2545 (0,8%) 13 / 2540 (0,5%) 1,54 [0,77;3,08]   10916 
    Cardiovascular death 101 / 2545 (4,0%) 81 / 2540 (3,2%) 1,24 [0,93;1,66]    
    Non fatal stroke 33 / 2545 (1,3%) 42 / 2540 (1,7%) 0,78 [0,50;1,23]    
    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 3,26% 4,21% -9,5‰
    stroke (fatal and non fatal) 7,07‰ 1,02% -3,2‰
    Haemmorhagic stroke 4,72‰ 2,36‰ 2,4‰
    Cardiovascular events 8,96% 10,24% -12,8‰
    Non fatal MI 3,69% 5,39% -17,0‰
    ischemic stroke 8,25‰ 1,30% -4,7‰
    Coronary death 1,41% 1,34% 0,8‰
    All cause death 4,44% 4,33% 1,1‰
    Major gastrointestinal bleeding 7,86‰ 5,12‰ 2,7‰
    Cardiovascular death 3,97% 3,19% 7,8‰
    Non fatal stroke 1,30% 1,65% -3,6‰


    Reference(s)

    Trials register # NCT00000614
    • . Thrombosis prevention trial: randomised trial of low-intensity oral anticoagulation with warfarin and low-dose aspirin in the primary prevention of ischaemic heart disease in men at increased risk. The Medical Research Council's General Practice Research Framework.. Lancet 1998 Jan 24;351:233-41
      Pubmed | Hubmed | Fulltext

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