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NCT00265239 Clinical Trial

Pilot Study of Edaravone to Treat Acute Myocardial Infarction

Myocardial Infarction Clinical Trial

Official title:
Effects of Edaravone in Patients With Acute Myocardial Infarction

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00265239
Other study ID # 310
Secondary ID
Status Completed
Phase Phase 4
First received December 13, 2005
Last updated September 12, 2014
Start date April 2001
Est. completion date June 2007

Study information
Verified date November 2007
Source Kumamoto University
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 104
Est. completion date June 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• edaravone
intravenous administration of 30mg Edaravone just before reperfusion therapy

Locations
Country Name City State
Japan Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University Kumamoto

Sponsors (2)
Lead Sponsor Collaborator
Kumamoto University Japan Heart Foundation

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Cardiac Death number of cardiac death 415±32 days No
Primary Nonfatal Myocardial Reinfarction number of nonfatal myocardial reinfarction 415days No
Primary Refractory Angina Pectoris number of refractory angina pectoris 415days No
Primary Nonfatal Ischemic Stroke number of nonfatal ischemic stroke 415days No
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