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

History of Changes

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:

MedlinePlus related topics: Heart Attack

U.S. FDA Resources

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


Ages Eligible for Study:	Child, Adult, Senior
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

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, see Learn About Clinical Studies.

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


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 Ischemia Pathologic Processes Necrosis Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases Postoperative Complications Phenylmethylpyrazolone Antipyrine	Free Radical Scavengers Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Anti-Inflammatory Agents Antirheumatic Agents

ClinicalTrials.gov processed this record on September 23, 2016

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