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The Melatonin Adjunct in the Acute myocaRdial Infarction Treated With Angioplasty

NCT00640094 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 272

Last updated 2020-07-22

No results posted yet for this study

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.

Conditions

  • Acute Myocardial Infarction

Interventions

DRUG

melatonin

Patients will receive a total intravenous melatonin dose of 12 mg + intracoronary melatonin dose of 2 mg. The intravenous dose will be distributed in a volume of 50 ml of a isotonic and sterile solution and administered by intravenous infusion during 60 minutes. The intracoronary dose will be distributed in a volume of 10 ml of a isotonic and sterile solution and administered as a bolus.

Sponsors & Collaborators

  • Alberto Domínguez Rodríguez

    lead OTHER

Principal Investigators

  • Alberto Dominguez-Rodriguez, MD, PhD, FESC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2016-03-31
Completion
2016-11-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00640094 on ClinicalTrials.gov