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  Introduction


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 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.