Pilot Study of Edaravone to Treat Acute Myocardial Infarction

This study has been completed.
Sponsor:
Collaborator:
Japan Heart Foundation
Information provided by:
Kumamoto University
ClinicalTrials.gov Identifier:
NCT00265239
First received: December 13, 2005
Last updated: September 12, 2014
Last verified: November 2007
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: No ]
    number of cardiac death

  • Nonfatal Myocardial Reinfarction [ Time Frame: 415days ] [ Designated as safety issue: No ]
    number of nonfatal myocardial reinfarction

  • Refractory Angina Pectoris [ Time Frame: 415days ] [ Designated as safety issue: No ]
    number of refractory angina pectoris

  • Nonfatal Ischemic Stroke [ Time Frame: 415days ] [ Designated as safety issue: No ]
    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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT00265239

Locations
Japan
Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University
Kumamoto, Japan, 860-8556
Sponsors and Collaborators
Kumamoto University
Japan Heart Foundation
Investigators
Study Chair: Hisao Ogawa, MD, PhD Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University
  More Information

No publications provided

ClinicalTrials.gov 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
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Reperfusion Injury
Cardiovascular Diseases
Heart Diseases
Ischemia
Myocardial Ischemia
Necrosis
Pathologic Processes
Postoperative Complications
Vascular Diseases
Phenylmethylpyrazolone
Antioxidants
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents

ClinicalTrials.gov processed this record on October 23, 2014