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Pilot Study of Edaravone to Treat Acute Myocardial Infarction

This study has been completed.
Japan Heart Foundation
Information provided by:
Kumamoto University Identifier:
First received: December 13, 2005
Last updated: September 12, 2014
Last verified: November 2007
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.

Condition Intervention Phase
Myocardial Infarction Reperfusion Injury Drug: edaravone Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Edaravone in Patients With Acute Myocardial Infarction

Resource links provided by NLM:

Further study details as provided by Kumamoto University:

Primary Outcome Measures:
  • Cardiac Death [ Time Frame: 415±32 days ]
    number of cardiac death

  • Nonfatal Myocardial Reinfarction [ Time Frame: 415days ]
    number of nonfatal myocardial reinfarction

  • Refractory Angina Pectoris [ Time Frame: 415days ]
    number of refractory angina pectoris

  • Nonfatal Ischemic Stroke [ Time Frame: 415days ]
    number of nonfatal ischemic stroke

Enrollment: 104
Study Start Date: April 2001
Study Completion Date: June 2007
Arms Assigned Interventions
Active Comparator: 1
Edaravone Group
Drug: edaravone
intravenous administration of 30mg Edaravone just before reperfusion therapy
No Intervention: 2
Placebo Group

Detailed Description:
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.

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00265239

Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University
Kumamoto, Japan, 860-8556
Sponsors and Collaborators
Kumamoto University
Japan Heart Foundation
Study Chair: Hisao Ogawa, MD, PhD Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University
  More Information Identifier: NCT00265239     History of Changes
Other Study ID Numbers: 310
Study First Received: December 13, 2005
Results First Received: May 19, 2014
Last Updated: September 12, 2014

Keywords provided by Kumamoto University:
Randomized Control Trial
ST-Elevation Myocardial Infarction
Coronary Angioplasty

Additional relevant MeSH terms:
Myocardial Infarction
Reperfusion Injury
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Postoperative Complications
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents processed this record on June 23, 2017