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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Myocardial Infarction Reperfusion Injury | Drug: edaravone | Phase 4 |
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 |

Arm | Intervention/treatment |
---|---|
Active Comparator: 1
Edaravone Group
|
Drug: edaravone
intravenous administration of 30mg Edaravone just before reperfusion therapy |
No Intervention: 2
Placebo Group
|
- Cardiac Death [ Time Frame: 415±32 days ]number of cardiac death
- Nonfatal Myocardial Reinfarction [ Time Frame: 415days ]number of nonfatal myocardial reinfarction
- Refractory Angina Pectoris [ Time Frame: 415days ]number of refractory angina pectoris
- Nonfatal Ischemic Stroke [ Time Frame: 415days ]number of nonfatal ischemic stroke

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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
Japan | |
Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University | |
Kumamoto, Japan, 860-8556 |
Study Chair: | Hisao Ogawa, MD, PhD | Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University |
ClinicalTrials.gov Identifier: | NCT00265239 |
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 |
Edaravone Randomized Control Trial ST-Elevation Myocardial Infarction Coronary Angioplasty |
Myocardial Infarction Reperfusion Injury Infarction 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 |