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See also:

  • All acute myocardial infarction clinical trials
  • All clinical trials of myocardial revascularization
  • All clinical trials of streptokinase
    		•  

    ISAM study, 1986

    Treatments

    Studied treatment 1.5 million IU of streptokinase over 1h
    Control treatment Placebo
    Concomittant treatment Héparine IV 5000 UI; aspirine IV 500 mg; méthylprednisolone IV 250 mg avant la perfusion de streptokinase ou de placebo. Puis, héparine IV 800-1000 UI/h pendant 72-96 h (TCA 2 à 3 fois le témoin), puis phenprocoumone pendant au moins 3 semaines (TP entre 20 et 25 %). Autres traitements prescrits si besoin.

    Patients

    Patients patients within six hours after the onset of symptoms of myocardial infarction
    Inclusion criteria IDM < 6h; sus-décalage ST de 1 mm en dérivation standard, et de 2 mm en précordiales
    Exclusion criteria Troubles hémorragiques, traitement par AVK, administration de streptokinase < 9 mois; valvulopathie en FA, pacemaker, HTA sévère résistante (PAS > 200 et/ou PAD > 120 mmHg); ulcère gastroduodénal < 6 mois, colite, varices oesophagiennes, anévrysme de l'aorte, massage cardiaque, ponction, traumatisme, chirurgie < 10 j; AVC, céphalée violente ou problème visuel inexpliqués; pathologie extracardiaque sévère

    Method and design

    Randomized effectives 859 / 882 (studied vs. control)
    Design Parallel groups
    Blinding double blind
    Follow-up duration 21 days
    Lost to follow-up ND
    Primary endpoint Mortality 21-day
    Withdrawals (T1/T0) ND /


    Results

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

    short term death

    54 / 859
         63 / 882
         0,88 [0,62;1,25]

    Major bleeding

    51 / 859
         13 / 882
         classic 4,03 [2,21;7,35]

    Long term death

    94 / 859
         98 / 882
         0,98 [0,75;1,29]     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 54 / 859 (6,3%) 63 / 882 (7,1%) 0,88 [0,62;1,25]    
    Major bleeding 51 / 859 (5,9%) 13 / 882 (1,5%) 4,03 [2,21;7,35]    
    Long term death 94 / 859 (10,9%) 98 / 882 (11,1%) 0,98 [0,75;1,29]    
    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 6,29% 7,14% -8,6‰
    Major bleeding 5,94% 1,47% 4,5%
    Long term death 10,94% 11,11% -1,7‰


    Reference(s)

    Trials register # NA
    • . A prospective trial of intravenous streptokinase in acute myocardial infarction (I.S.A.M.). Mortality, morbidity, and infarct size at 21 days. The I.S.A.M. Study Group.. N Engl J Med 1986 Jun 5;314:1465-71
      Pubmed | Hubmed | Fulltext

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