Free radicals, reperfusion and myocardial infarction therapy: European Myocardial Infarction Project--free radicals pilot study. EMIP-FR Pilot Study Group.

Reperfusion injury due to overproduction of free radicals may reduce the efficacy of thrombolytic therapy. Trimetazidine is an agent which could prevent or limit the deleterious effects of free radicals on the myocardium and could, therefore, improve the prognosis for patients with acute myocardial infarction (MI) receiving thrombolytic therapy. In this pilot study, 136 patients with suspected acute MI were randomized to receive either 40 mg trimetazidine as an intravenous (i.v.) bolus followed by an infusion of trimetazidine at 60 mg.24 h-1 for 48 h (n = 69) or matching placebo (n = 67). Stratification was based on the use ('T' stratum; n = 69) or not ('NT' stratum; n = 67) of a thrombolytic. The mean age of patients was 64.2 years (+/- 12.7), and the final diagnosis at discharge was confirmed MI in 92% of patients. No statistically significant difference was observed for the occurrence of major or minor adverse events. Eight patients died before discharge; three in the trimetazidine group and five in the placebo group. The observed compliance was good and the low rate of adverse events suggests that the study treatment can be considered safe in patients with suspected acute MI, either receiving thrombolytic treatment or not. The study is feasible and no major practical problem can be expected from this simple protocol. We started recruitment of patients for the large-scale mortality and morbidity trial in October 1992.