Pilot Study of Edaravone to Treat Acute Myocardial Infarction
Effects of Edaravone in Patients With Acute Myocardial Infarction
1 other identifier
interventional
104
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Apr 2001
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2001
CompletedFirst Submitted
Initial submission to the registry
December 13, 2005
CompletedFirst Posted
Study publicly available on registry
December 14, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2007
CompletedResults Posted
Study results publicly available
September 15, 2014
CompletedSeptember 15, 2014
November 1, 2007
December 13, 2005
May 19, 2014
September 12, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Cardiac Death
number of cardiac death
415±32 days
Nonfatal Myocardial Reinfarction
number of nonfatal myocardial reinfarction
415days
Refractory Angina Pectoris
number of refractory angina pectoris
415days
Nonfatal Ischemic Stroke
number of nonfatal ischemic stroke
415days
Study Arms (2)
1
ACTIVE COMPARATOREdaravone Group
2
NO INTERVENTIONPlacebo Group
Interventions
Eligibility Criteria
You may qualify if:
- Initial AMI patients admitted to the investigators' institution within 6 hours of symptom onset and treated primary percutaneous coronary intervention.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kumamoto Universitylead
- Japan Heart Foundationcollaborator
Study Sites (1)
Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University
Kumamoto, 860-8556, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Kenichi Tsujita
- Organization
- Kumamoto University
Study Officials
- STUDY CHAIR
Hisao Ogawa, MD, PhD
Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 13, 2005
First Posted
December 14, 2005
Study Start
April 1, 2001
Study Completion
June 1, 2007
Last Updated
September 15, 2014
Results First Posted
September 15, 2014
Record last verified: 2007-11