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See also:

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

    ISIS-2 (SK) study, 1988

    Treatments

    Studied treatment 1-hour intravenous infusion of 1.5 MU of streptokinase
    Control treatment Placebo
    Concomittant treatment Au choix du médecin

    Patients

    Patients patients within 24h of the onset of suspected acute myocardial infarction
    Inclusion criteria IDM < 24 h
    Exclusion criteria Indication ou contre-indication claire à la streptokinase ou à l'aspirine; antécédent AVC, hémorragie gastro-intestinale ou ulcère; ponction artérielle récente; traumatisme sévère récent; allergie à la streptokinase ou à l'aspirine; HTA sévère persistante; faible risque de mortalité cardiaque; pathologie extra-cardiaque sévère

    Method and design

    Randomized effectives 8592 / 8595 (studied vs. control)
    Design plan factoriel 2*2
    Blinding double blind
    Follow-up duration 15 mo
    Lost to follow-up ND
    Number of centre 417
    Primary endpoint CV Mortality 35-day
    Withdrawals (T1/T0) ND /


    Results

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

    short term death

    791 / 8592
         1029 / 8595
         0,77 [0,70;0,84]

    stroke (fatal and non fatal)

    61 / 8592
         67 / 8595
         0,91 [0,64;1,29]

    Major bleeding

    46 / 8592
         18 / 8595
         classic 2,56 [1,48;4,40]     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 791 / 8592 (9,2%) 1029 / 8595 (12,0%) 0,77 [0,70;0,84]    
    stroke (fatal and non fatal) 61 / 8592 (0,7%) 67 / 8595 (0,8%) 0,91 [0,64;1,29]    
    Major bleeding 46 / 8592 (0,5%) 18 / 8595 (0,2%) 2,56 [1,48;4,40]    
    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 9,21% 11,97% -27,7‰
    stroke (fatal and non fatal) 7,10‰ 7,80‰ -0,7‰
    Major bleeding 5,35‰ 2,09‰ 3,3‰


    Reference(s)

    Trials register # NA
    • . Randomised trial of intravenous streptokinase, oral aspirin, both, or neither among 17,187 cases of suspected acute myocardial infarction: ISIS-2. ISIS-2 (Second International Study of Infarct Survival) Collaborative Group.. Lancet 1988 Aug 13;2:349-60
      Pubmed | Hubmed | Fulltext

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