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Pilot Study of Edaravone to Treat Acute Myocardial Infarction

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ClinicalTrials.gov Identifier: NCT00265239
Recruitment Status : Completed
First Posted : December 14, 2005
Results First Posted : September 15, 2014
Last Update Posted : September 15, 2014
Sponsor:
Collaborator:
Japan Heart Foundation
Information provided by:
Kumamoto University

Study Description
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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.

Study Design
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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

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 1
Edaravone Group
 Drug: edaravone
intravenous administration of 30mg Edaravone just before reperfusion therapy
No Intervention: 2
Placebo Group


Outcome Measures
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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


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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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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 ClinicalTrials.gov identifier (NCT number): NCT00265239


Locations
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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
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Study Chair: Hisao Ogawa, MD, PhD Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University
More Information
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ClinicalTrials.gov Identifier: NCT00265239     History of Changes
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:
Edaravone
Randomized Control Trial
ST-Elevation Myocardial Infarction
Coronary Angioplasty

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