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Pilot Study of Edaravone to Treat Acute Myocardial Infarction

Primary Purpose

Myocardial Infarction, Reperfusion Injury

Status
Completed
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
edaravone
Sponsored by
Kumamoto University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Infarction focused on measuring Edaravone, Randomized Control Trial, ST-Elevation Myocardial Infarction, Coronary Angioplasty

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

1

2

Arm Description

Edaravone Group

Placebo Group

Outcomes

Primary Outcome Measures

Cardiac Death
number of cardiac death
Nonfatal Myocardial Reinfarction
number of nonfatal myocardial reinfarction
Refractory Angina Pectoris
number of refractory angina pectoris
Nonfatal Ischemic Stroke
number of nonfatal ischemic stroke

Secondary Outcome Measures

Full Information

First Posted
December 13, 2005
Last Updated
September 12, 2014
Sponsor
Kumamoto University
Collaborators
Japan Heart Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00265239
Brief Title
Pilot Study of Edaravone to Treat Acute Myocardial Infarction
Official Title
Effects of Edaravone in Patients With Acute Myocardial Infarction
Study Type
Interventional

2. Study Status

Record Verification Date
November 2007
Overall Recruitment Status
Completed
Study Start Date
April 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Kumamoto University
Collaborators
Japan Heart Foundation

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction, Reperfusion Injury
Keywords
Edaravone, Randomized Control Trial, ST-Elevation Myocardial Infarction, Coronary Angioplasty

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
104 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Edaravone Group
Arm Title
2
Arm Type
No Intervention
Arm Description
Placebo Group
Intervention Type
Drug
Intervention Name(s)
edaravone
Intervention Description
intravenous administration of 30mg Edaravone just before reperfusion therapy
Primary Outcome Measure Information:
Title
Cardiac Death
Description
number of cardiac death
Time Frame
415±32 days
Title
Nonfatal Myocardial Reinfarction
Description
number of nonfatal myocardial reinfarction
Time Frame
415days
Title
Refractory Angina Pectoris
Description
number of refractory angina pectoris
Time Frame
415days
Title
Nonfatal Ischemic Stroke
Description
number of nonfatal ischemic stroke
Time Frame
415days

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hisao Ogawa, MD, PhD
Organizational Affiliation
Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University
City
Kumamoto
ZIP/Postal Code
860-8556
Country
Japan

12. IPD Sharing Statement

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Pilot Study of Edaravone to Treat Acute Myocardial Infarction

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