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See also:

  • All acute myocardial infarction clinical trials
  • All clinical trials of myocardial revascularization
  • All clinical trials of t-PA
    		•  

    ASSET study, 1988

    Treatments

    Studied treatment rt-PA 100 mg
    Control treatment Placebo
    Concomittant treatment Héparine en IV bolus de 5000 UI avant administration du traitement étudié, puis 1000 UI/h pendant 21 h après administration du thrombolytique.

    Patients

    Patients patient with suspected acute myocardial infarction
    Inclusion criteria IDM aigu < 5 h
    Exclusion criteria Hémorragie majeure ou AVC < 6 mois; blessure importante ou chirurgie < 6 sem; réanimation cardiaque nécessaire; PAS > 200 mm Hg; traitement par anticoagulants, problèmes de coagulation; ulcère gastro-duodénal évolutif, rétinopathie diabétique proliférative, grossesse, sensibilité à la gentamycine (utilisée dans la préparation du rt-PA; autres problèmes organiques ou psychiatriques sérieux; domicile éloigné de l'hôpital (suivi difficile)

    Method and design

    Randomized effectives 2516 / 2495 (studied vs. control)
    Design Parallel groups
    Blinding double blind
    Follow-up duration 6 months
    Lost to follow-up ND
    Primary endpoint death at 6 mo
    Withdrawals (T1/T0) ND /


    Results

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

    short term death

    182 / 2516
         244 / 2495
         0,74 [0,62;0,89]

    stroke (fatal and non fatal)

    28 / 2516
         25 / 2495
         1,11 [0,65;1,90]

    Major bleeding

    35 / 2516
         12 / 2495
         classic 2,89 [1,50;5,56]

    Long term death

    261 / 2516
         328 / 2495
         0,79 [0,68;0,92]     0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial    		 Ref
    Studied treat. Control treat.
    short term death 182 / 2516 (7,2%) 244 / 2495 (9,8%) 0,74 [0,62;0,89]    
    stroke (fatal and non fatal) 28 / 2516 (1,1%) 25 / 2495 (1,0%) 1,11 [0,65;1,90]    
    Major bleeding 35 / 2516 (1,4%) 12 / 2495 (0,5%) 2,89 [1,50;5,56]    
    Long term death 261 / 2516 (10,4%) 328 / 2495 (13,1%) 0,79 [0,68;0,92]    
    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
    Endpoint Events rate Absolute risk
    reduction (ARR)
    Studied treat. Control treat.
    short term death 7,23% 9,78% -25,5‰
    stroke (fatal and non fatal) 1,11% 1,00% 1,1‰
    Major bleeding 1,39% 4,81‰ 9,1‰
    Long term death 10,37% 13,15% -27,7‰


    Reference(s)

    Trials register # NA
    • Wilcox RG, von der Lippe G, Olsson CG, Jensen G, Skene AM, Hampton JR. Trial of tissue plasminogen activator for mortality reduction in acute myocardial infarction. Anglo-Scandinavian Study of Early Thrombolysis (ASSET).. Lancet 1988 Sep 3;2:525-30
      Pubmed | Hubmed | Fulltext

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