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Pilot Study of Edaravone to Treat Acute Myocardial Infarction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00265239
Recruitment Status : Completed
First Posted : December 14, 2005
Results First Posted : September 15, 2014
Last Update Posted : September 15, 2014
Japan Heart Foundation
Information provided by:
Kumamoto University

Brief Summary:
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 or disease Intervention/treatment Phase
Myocardial Infarction Reperfusion Injury Drug: edaravone Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Edaravone in Patients With Acute Myocardial Infarction
Study Start Date : April 2001
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
Drug Information available for: Edaravone

Arm Intervention/treatment
Active Comparator: 1
Edaravone Group
Drug: edaravone
intravenous administration of 30mg Edaravone just before reperfusion therapy

No Intervention: 2
Placebo Group

Primary Outcome Measures :
  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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00265239

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Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University
Kumamoto, Japan, 860-8556
Sponsors and Collaborators
Kumamoto University
Japan Heart Foundation
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Study Chair: Hisao Ogawa, MD, PhD Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University
Layout table for additonal information Identifier: NCT00265239    
Other Study ID Numbers: 310
First Posted: December 14, 2005    Key Record Dates
Results First Posted: September 15, 2014
Last Update Posted: September 15, 2014
Last Verified: November 2007
Keywords provided by Kumamoto University:
Randomized Control Trial
ST-Elevation Myocardial Infarction
Coronary Angioplasty
Additional relevant MeSH terms:
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Myocardial Infarction
Reperfusion Injury
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Postoperative Complications
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs