The Melatonin Adjunct in the Acute myocaRdial Infarction Treated With Angioplasty
Status:
Terminated
Trial end date:
2016-11-01
Target enrollment:
Participant gender:
Summary
Background: Experimental studies have documented the beneficial effects of the endogenously
produced antioxidant, melatonin, in reducing tissue damage and limiting cardiac
pathophysiology in models of experimental ischemia-reperfusion. Melatonin confers
cardioprotection against ischemia-reperfusion injury most likely through its direct free
radical scavenging activities and its indirect actions in stimulating antioxidant enzymes.
These actions of melatonin permit it to reduce molecular damage and limit infarct size in
experimental models of transient ischemia and subsequent reperfusion.
Study design: The Melatonin Adjunct in the acute myocaRdial Infarction treated with
Angioplasty (MARIA) trial is a prospective, randomized, double-blind, placebo-controlled,
phase 2 study of the intravenous administration of melatonin. The primary efficacy end point
of this study is to determine whether melatonin treatment reduces infarct size determined by
cardiac magnetic resonance 5-7 days post-reperfusion. Other secondary end points will be the
clinical events occurring within the first year: death, sustained ventricular arrhythmias,
resuscitation from cardiac arrest, cardiogenic shock, heart failure, major bleedings ,
stroke, need for revascularization, recurrent ischemia, re-infarctions and rehospitalization;
and changes in left ventricular ejection fraction from baseline to 4 months of follow-up.
Implications: The MARIA trial tests a novel pharmacologic agent, melatonin, in patients with
acute myocardial infarction and the hypothesis that it will confer cardioprotection against
ischemia-reperfusion injury. If successful, the finding would support the use of melatonin in
therapy of ischemic-reperfusion injury of the heart.