GISSI — A randomized trial with intravenous streptokinase in acute myocardial infarction. Preliminary results

  • F. Rovelli
  • F. Mauri
Conference paper


In 1983 the first meeting of Italian cardiologists took place in Milan to draw up the protocol for the study of streptokinase in myocardial infarction, the GISSI trial. The scientific committee, having obtained all the information available at that time (1–3, 5–14, 16), decided to test the effects of brief duration, intravenous administration of streptokinase on in-hospital mortality, medium term mortality, six and twelve months mortality, and type and frequency of cardiac morbidity within six months of treatment. As the in-hospital mortality for acute myocardial infarction previously estimated in Italy by a specific enquiry ranged between 12 and 15%, we needed to recruit about 11000 patients in order to demonstrate a statistically significant reduction of 20%. This reduction was considered the main clinical endpoint. In order to ensure maximum cooperation from the coronary care units (CCU) active at that time in Italy, the protocol had to be very simple. The study was planned following a controlled multicentre open level design with central randomization (4–15). The cooperating centres had to comply with only very few operative steps.


Acute Myocardial Infarction Thrombolytic Agent Previous Myocardial Infarction Coronary Care Unit Operative Step 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.


Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.


  1. 1.
    Braunwald E (1985) The aggressive treatment of acute myocardial infarction. Circulation 71:1087–1092PubMedCrossRefGoogle Scholar
  2. 2.
    Intracoronary thrombolysis (Editorial) (1983) Lancet ii:606Google Scholar
  3. 3.
    Kennedy JK, Titchie JL, Davis KB, Fritz JK (1983) Western Washington randomized trial of intracoronary streptokinase in acute myocardial infarction. N Engl J Med 309:1477–1482PubMedCrossRefGoogle Scholar
  4. 4.
    Protocol of ISIS 2 (International Studies of Infarct Survival) (1985) Radcliffe Infirmary, OxfordGoogle Scholar
  5. 5.
    Simoons ML, van der Brand M, De Zwaan C et al (1985) Improved survival after early thrombolysis in acute myocardial infarction. A randomised trial by the Interuniversity Cardiology Institute in the Netherlands. Lancet ii:578–581CrossRefGoogle Scholar
  6. 6.
    Spann JF, Sherry S (1984) Coronary thrombolysis for evolving myocardial infarction. Drugs 28:465–483PubMedCrossRefGoogle Scholar
  7. 7.
    Stampfer MJ, Goldhaber SZ, Yusuf S, Peto R, Hennekens CH (1982) Effect of intravenous streptokinase on acute myocardial infarction. Pooled results from randomized trials. N Engl J Med 307:1180–1182PubMedCrossRefGoogle Scholar
  8. 8.
    Tendera MP, Campbell WB, Tennant SN, Ray WA (1985) Factors influencing probability of reperfusion with intracoronary ostial infusion of thrombolytic agent in patients with acute myocardial infarction. Circulation 71:124–128PubMedCrossRefGoogle Scholar
  9. 9.
    The ISAM Study Group (1985) Intravenous Streptokinase in Acute Myocardial Infarction: preliminary results of a prospective controlled trial (ISAM). Presented at 58th Congress of the American Heart Association, Washington, Nov 10–14 1985Google Scholar
  10. 10.
    Thrombolytic therapy in treatment. Summary of an N.I.H. consensus conference (1980). Br Med J 280:1585–1587CrossRefGoogle Scholar
  11. 11.
    TIMI Study Group (1985) The Thrombolysis in Myocardial Infarction (TIMI) trial. Phase I findings. N Engl J Med 312:932–936Google Scholar
  12. 12.
    Verstraete M (1985) Even if the efficacy of intracoronary thrombolysis is proven, this approach is a death issue in terms of public health. In: Davidson JF, Donati MB, Cocchieri S (eds) Progress in Fibrinolysis, Vol VII. Churchill Livingstone, Edinburgh, pp 25–29Google Scholar
  13. 13.
    Verstraete M (1985) Intravenous administration of a thrombolytic agent is the only realistic therapeutic approach in evolving myocardial infarction. Eur Heart J 6:586–593PubMedGoogle Scholar
  14. 14.
    Verstraete M, Bernard R, Bory M et al (1985) Randomised trial of intravenous recombinant tissue-type plasminogen activator versus intravenous streptokinase in acute myocardial infarction. Lancet i:842–847CrossRefGoogle Scholar
  15. 15.
    Yusuf S, Collins R, Peto R (1984) Why do we need some large, simple randomized trials? Stat Med 3:409–420PubMedCrossRefGoogle Scholar
  16. 16.
    Yusuf S, Collins R, Peto R et al. (1985) Intravenous and intracoronary fibrinolytic therapy in acute myocardial infarction: overview of results on mortality, reinfarction and side-effects from 33 randomized controlled trials. Eur Heart J 6:556–585PubMedGoogle Scholar

Copyright information

© Springer-Verlag Berlin Heidelberg 1986

Authors and Affiliations

  • F. Rovelli
    • 1
  • F. Mauri
    • 1
    • 2
  1. 1.the Gruppo Italiano per lo Studio della Streptochinasi nell’ Infarcto Miocardico Divisione CardiologicaOspedale NiguardaMilanItaly
  2. 2.Divisione Cardiologica „Centro A. de Gasperis“Ospedale Niguarda - Ca’GrandaMilano-NiguardaItaly

Personalised recommendations