Objective: To evaluate if and to what extent pharmacological treatments aimed at different and probably complementary risk factors for atherosclerosis and/or thrombosis improve the profile (in terms of survival, morbidity, quality of health) of patients surviving beyond the hospital phase of acute myocardial infarction.

Study design: Open controlled clinical trial with central randomisation of patients, following a 2x2 factorial design, to fish oil, vitamin E, both or neither. Patients with high cholesterol levels (> 250 mg%) subsequently randomised to receive pravastatin treatment 6 months after the event.

Population randomised: the study was started in October 1993 and randomisation terminated in October 1995, after the inclusion of 11,324 patients. A minimum follow-up period of 3 years is planned.

Results: expected in March 1999. <On-line results>

References:

Protocollo dello studio GISSI-Prevenzione. Studio di intervento preventivo sulle componenti aterosclerotica e trombotica del rischio post-infarto. G Ital Cardiol 1993; 23: 1053-1061.