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
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
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
NCT ID
NCT00265239
First Posted
December 13, 2005
Last Updated
September 12, 2014
Sponsor
Kumamoto University
Collaborators
Japan Heart Foundation
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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