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The MARIA randomized trial evaluated the efficacy and safety of melatonin for the reduction of reperfusion injury in patients undergoing revascularization for ST-elevation myocardial infarction ( STEMI). This was a prespecified interim analysis. A total of 146 patients presenting with STEMI within 6 hours of chest pain onset were randomized to receive intravenous and intracoronary melatonin (n=73) or placebo (n=73) during primary percutaneous coronary intervention ( PPCI). Primary endpoint was myocardial infarct size as assessed by magnetic resonance imaging ( MRI) at 6 ± 2 days. Secondary endpoints were changes in left ventricular volumes and ejection fraction ( LVEF) at 130 ± 10 days post- PPCI and adverse events during the first year. No significant differences in baseline characteristics were observed between groups. MRI was performed in 108 patients (86.4%). Myocardial infarct size by MRI evaluated 6 ± 2 days post- PPCI, did not differ between melatonin and placebo groups ( P=.63). Infarct size assessed by MRI at 130 ± 10 days post- PPCI, performed in 91 patients (72.8%), did not show statistically significant differences between groups ( P=.27). The recovery of LVEF from 6 ± 2 to 130 ± 10 days post- PPCI was greater in the placebo group (60.0 ± 10.4% vs 53.1 ± 12.5%, P=.008). Both left ventricular end-diastolic and end-systolic volumes were lower in the placebo group ( P=.01). The incidence of adverse events at 1 year was comparable in both groups ( P=.150). Thus, in a nonrestricted STEMI population, intravenous and intracoronary melatonin was not associated with a reduction in infarct size and has an unfavourable effect on the ventricular volumes and LVEF evolution. Likewise, there is lack of toxicity of melatonin with the doses used. [ABSTRACT FROM AUTHOR]