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See also:

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

    International Study Group study, 1990

    Treatments

    Studied treatment tPA 100 mg en IV en 3 h (10 mg en bolus, puis 50 mg en 1 h, puis 20 mg/h pendant 2 h)
    Control treatment Streptokinase 1.5 MU en IV de 30 à 60 min
    Concomittant treatment Aspirine (300-325 mg/j) et aténolol en IV (5-10 mg/j) sauf contre-indication

    Patients

    Patients patients with suspected acute myocardial infarction of less than 6 h duration
    Inclusion criteria Douleur thoracique + sus-décalage ST > ou = 1 mm en dérivation standard ou > ou = 2 mm en précordiales; début des symptômes < 6 h
    Exclusion criteria Chirurgie, examen invasif ou traumatisme < ou = 2 sem; hémorragie récente; AVC < ou = 6 mois; HTA non contrôlée (PAS > ou = 200 et/ou PAD > ou = 110 mmHg); traitement par streptokinase < 6 mois

    Method and design

    Randomized effectives 10372 / 10396 (studied vs. control)
    Design Plan factoriel 2*2
    Blinding double blind
    Follow-up duration 6 mo
    Lost to follow-up 1.5%
    Primary endpoint in hospital death
    Withdrawals (T1/T0) ND /


    Results

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

    short term death

    929 / 10372
         887 / 10396
         1,05 [0,96;1,15]

    stroke (fatal and non fatal)

    138 / 10372
         98 / 10396
         1,41 [1,09;1,83]

    Major bleeding

    64 / 10372
         96 / 10396
         0,67 [0,49;0,92]

    Long term death

    1278 / 10372
         1220 / 10396
         1,05 [0,98;1,13]     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 929 / 10372 (9,0%) 887 / 10396 (8,5%) 1,05 [0,96;1,15]    
    stroke (fatal and non fatal) 138 / 10372 (1,3%) 98 / 10396 (0,9%) 1,41 [1,09;1,83]    
    Major bleeding 64 / 10372 (0,6%) 96 / 10396 (0,9%) 0,67 [0,49;0,92]    
    Long term death 1278 / 10372 (12,3%) 1220 / 10396 (11,7%) 1,05 [0,98;1,13]    
    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 8,96% 8,53% 4,2‰
    stroke (fatal and non fatal) 1,33% 9,43‰ 3,9‰
    Major bleeding 6,17‰ 9,23‰ -3,1‰
    Long term death 12,32% 11,74% 5,9‰


    Reference(s)

    Trials register # NA
    • . In-hospital mortality and clinical course of 20,891 patients with suspected acute myocardial infarction randomised between alteplase and streptokinase with or without heparin. The International Study Group.. Lancet 1990;336:71-5
      Pubmed | Hubmed | Fulltext

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