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Completed

NCT Number: NCT00265239

Pilot Study of Edaravone to Treat Acute Myocardial Infarction

Early reperfusion therapy has improved the clinical outcomes of patients with acute myocardial infarction (AMI), but these benefits are limited in some patients by reperfusion injuries. There is now increasing evidence that reactive oxygen species cause reperfusion injury. This study was designed to examine the effects of edaravone, a novel free radical scavenger, in patients with AMI.

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Key information

Conditions

Myocardial Infarction Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Reperfusion Injury ST Elevation Myocardial Infarction Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University

Kumamoto, 860-8556, Japan

About this study

Initial AMI patients were randomly assigned to receive 30 mg of edaravone or a placebo intravenously just before reperfusion. We compared infarct size, using serial determination of serum biomarkers and Q wave formations, and the incidence of reperfusion arrhythmia between the groups. Cardiovascular event-free curves were estimated by Kaplan-Meier method. In addition, we determined serum thioredoxin levels, an oxidative stress marker, to assess the antioxidant effect of edaravone.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Initial AMI patients admitted to the investigators' institution within 6 hours of symptom onset and treated primary percutaneous coronary intervention.

Exclusion criteria

  • Renal insufficiency defined as serum creatinine > 1.2 mg/dl and altered hepatic function defined as serum asparate aminotransferase > 50 IU/L, alanine aminotransferase > 50 IU/L and total bilirubin > 1.2 mg/dl.

Treatment and study plan

Edaravone

Drug

intravenous administration of 30mg Edaravone just before reperfusion therapy

Primary outcomes

  1. Cardiac Death

    Time frame: 415±32 days

    number of cardiac death

  2. Nonfatal Myocardial Reinfarction

    Time frame: 415days

    number of nonfatal myocardial reinfarction

  3. Refractory Angina Pectoris

    Time frame: 415days

    number of refractory angina pectoris

  4. Nonfatal Ischemic Stroke

    Time frame: 415days

    number of nonfatal ischemic stroke

Sponsors and collaborators

Lead sponsor

Kumamoto University

Other

Collaborators

  • Japan Heart Foundation

Registry information

Official study title

Effects of Edaravone in Patients With Acute Myocardial Infarction

Important dates

Study start
2001
Study completion
2007
First posted
Dec 14, 2005
Registry last updated
Sep 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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