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See also:

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

    ISIS III (SK/APSAC) study, 1992

    Treatments

    Studied treatment Streptokinase 1.5 MU infused over about 1 h
    Control treatment anisoylated plasminogen-streptokinase activator complex (APSAC), anistreplase: 30 U over about 3 min
    Concomittant treatment Aspirine 162 mg/j immédiatement et pendant 1 mois

    Patients

    Patients patients within 24 h of the onset of suspected acute myocardial infarction
    Inclusion criteria IDM certains ou incertains < 24 h
    Exclusion criteria Contre-indication aux 3 fibrinolytiques étudiés; risque élevé d'hémorragies (ulcère, traumatisme récent, allergie à la streptokinase, AVC); faible risque cardiaque ou pathologie létale intercurrente

    Method and design

    Randomized effectives 13780 / 13773 (studied vs. control)
    Design Plan factoriel 3 (ou 4) *2
    Blinding double blind
    Follow-up duration 6 mo
    Lost to follow-up ND
    Number of centre 914
    Geographic area International 17 countries
    Primary endpoint Mortality 35-day
    Withdrawals (T1/T0) ND /


    Results

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

    short term death

    1455 / 13780
         1448 / 13773
         1,00 [0,94;1,08]

    stroke (fatal and non fatal)

    141 / 13780
         172 / 13773
         0,82 [0,66;1,02]

    Major bleeding

    118 / 13780
         138 / 13773
         0,85 [0,67;1,09]

    Long term death

    1929 / 13780
         1887 / 13773
         1,02 [0,96;1,08]     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 1455 / 13780 (10,6%) 1448 / 13773 (10,5%) 1,00 [0,94;1,08]    
    stroke (fatal and non fatal) 141 / 13780 (1,0%) 172 / 13773 (1,2%) 0,82 [0,66;1,02]    
    Major bleeding 118 / 13780 (0,9%) 138 / 13773 (1,0%) 0,85 [0,67;1,09]    
    Long term death 1929 / 13780 (14,0%) 1887 / 13773 (13,7%) 1,02 [0,96;1,08]    
    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 10,56% 10,51% 0,5‰
    stroke (fatal and non fatal) 1,02% 1,25% -2,3‰
    Major bleeding 8,56‰ 1,00% -1,5‰
    Long term death 14,00% 13,70% 3,0‰


    Reference(s)

    Trials register # NA
    • . ISIS-3: a randomised comparison of streptokinase vs tissue plasminogen activator vs anistreplase and of aspirin plus heparin vs aspirin alone among 41,299 cases of suspected acute myocardial infarction. ISIS-3 (Third International Study of Infarct Survival) Collaborative Group.. Lancet 1992;339:753-70
      Pubmed | Hubmed | Fulltext

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