Objective
Efficacy comparison of two thrombolytic treatments, streptokinase (SK) and alteplase (tPA), followed - or not - by treatment with subcutaneous heparin, on a combined endpoint of in-hospital mortality and left ventricular damage in patients with acute myocardial infarction (AMI).

Study design
Open controlled clinical trial with central randomisation of AMI patients within 6 hours from the onset of symptoms; allocation to SK or tPA and to heparin or no heparin (starting 12 hours after thrombolytic infusion) following a 2x2 factorial design.

Population randomised
12,490 patients in 17 months, from February 1988 to July 1989. Further 8401 patients were randomised in the GISSI international extension (with the participation of 13 countries participated), carried out with the same protocol and with the only mortality as endpoint.