Pilot Study of Edaravone to Treat Acute Myocardial Infarction

Phase 4

Completed

• Conditions: Myocardial Infarction; Reperfusion Injury
• Interventions: Drug: edaravone

• Registration Number: NCT00265239
• Lead Sponsor: Kumamoto University

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.

Study Timeline

• Study Start: 2001-04
• Study First Submitted: 2005-12-13
• Study First Submitted QC: 2005-12-13
• Study First Posted: 2005-12-14
• Study Completion: 2007-06
• Status Verified: 2007-11
• Results First Submitted: 2014-05-19
• Results First Submitted QC: 2014-09-12
• Last Update Submitted: 2014-09-12
• Results First Posted: 2014-09-15
• Last Update Posted: 2014-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	edaravone	Edaravone Group

Primary Outcome Measures

Name	Time	Method
Cardiac Death	415±32 days	number of cardiac death
Nonfatal Myocardial Reinfarction	415days	number of nonfatal myocardial reinfarction
Refractory Angina Pectoris	415days	number of refractory angina pectoris
Nonfatal Ischemic Stroke	415days	number of nonfatal ischemic stroke

Trial Locations

Locations (1)

Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University; 🇯🇵 Kumamoto, Japan