GISSI — A randomized trial with intravenous streptokinase in acute myocardial infarction. Preliminary results
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.
KeywordsAcute Myocardial Infarction Thrombolytic Agent Previous Myocardial Infarction Coronary Care Unit Operative Step
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