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See also:

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

    GISSI II study, 1990

    Treatments

    Studied treatment alteplase 100 mg infused intravenously over 3 h
    Control treatment streptokinase 1.5 MU infused intravenously over 30-60 min
    Concomittant treatment Aspirine (300-325 mg/j) et aténolol en IV (5-10 mg/j) sauf contre-indication

    Patients

    Patients patients with acute myocardial infarction within 6 h from onset of symptoms
    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 6182 / 6199 (studied vs. control)
    Design Plan factoriel 2*2
    Blinding open
    Follow-up duration 6 mo
    Lost to follow-up ND
    Number of centre NA
    Geographic area International 14 countries
    Primary endpoint Mortality in-hospital
    Withdrawals (T1/T0) ND /


    Results

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

    short term death

    556 / 6182
         536 / 6199
         1,04 [0,93;1,16]

    stroke (fatal and non fatal)

    70 / 6182
         54 / 6199
         1,30 [0,91;1,85]

    Major bleeding

    34 / 6182
         61 / 6199
         0,56 [0,37;0,85]     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 556 / 6182 (9,0%) 536 / 6199 (8,6%) 1,04 [0,93;1,16]    
    stroke (fatal and non fatal) 70 / 6182 (1,1%) 54 / 6199 (0,9%) 1,30 [0,91;1,85]    
    Major bleeding 34 / 6182 (0,5%) 61 / 6199 (1,0%) 0,56 [0,37;0,85]    
    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 8,99% 8,65% 3,5‰
    stroke (fatal and non fatal) 1,13% 8,71‰ 2,6‰
    Major bleeding 5,50‰ 9,84‰ -4,3‰


    Reference(s)

    Trials register # NA
    • . GISSI-2: a factorial randomised trial of alteplase versus streptokinase and heparin versus no heparin among 12,490 patients with acute myocardial infarction. Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto Miocardico.. Lancet 1990;336:65-71
      Pubmed | Hubmed | Fulltext

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