Edaravone, a free radical scavenger, is a novel neuroprotective agent, and argatroban is a selective thrombin inhibitor. Both the drugs were approved by the Japanese Government, and have frequently been used for the treatment of acute brain infarction in Japan. The effect of combination therapy of these drugs, however, has not yet been elucidated. This study will test the safety and efficacy of the combination therapy with these agents in patients with acute non-cardioembolic and non-lacunar ischemic stroke.

Condition	Intervention	Phase
Acute ischemic stroke (nonlacunar and noncardioembolic)	Drug: Edaravone	Phase IV

Further Study Details: 

Primary Outcomes: Modified Rankin Scale score at 3 months; Symptomatic intracranial hemorrhage for the initial 3 weeks
Secondary Outcomes: NIHSS score, JSS score, Barthel Index, modified Rankin Scale score at various time-points; Various adverse effects for the 3 months
Expected Total Enrollment:  800

Ages Eligible for Study:  20 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Acute ischemic stroke<24 hours of onset
• Measurable neurological deficits caused by the present attack, ranging from 1 to 22 of NIHSS score on admission

Exclusion Criteria:

• Definite or possible cardiogenic brain infarction
• Definite lacunar infarction
• Prior ischemic stroke within 6 months
• Evidence of hemorrhagic brain infarction, epidural hematoma, intracerebral hematoma, or intraventricular hemorrhage
• Severe consciousness disturbances (semicoma to deep coma)
• Neurological signs clearing spontaneously
• Disability of 2 or more of mRS score before the index stroke aPTT being out of the normal range or 1.5 times longer than the pretreatment value
• If taking an oral anticoagulant, INR being 1.6 or more, or no INR data
• Treatment with urokinase, t-PA, heparin, ozagrel sodium, warfarin, antiplatelet except for aspirin before the enrollment
• Intravascular surgery, surgical operation, hyperbaric oxygen therapy, hypothermia therapy before the enrollment
• Serum creatinine >1.5 mg/dL
• Severe hepatic or cardiac disorders, infectious disorders, dehydration, etc.
• Neoplasm
• Pregnancy
• Hypersensitivity to test drugs

Please refer to this study by ClinicalTrials.gov identifier  NCT00153946

Takenori Yamaguchi, MD, PhD      81-6-6832-7000    tyamaguc@ncvc.go.jp

Japan, Osaka
      EAST Study Office, National Cardiovascular Center, 5-7-1 Fujishirodai, Suita,  Osaka,  565-8565,  Japan; Recruiting

Study chairs or principal investigators

Takenori Yamaguchi, MD, PhD,  Study Chair,  National Cardiovascular Center   
Takenori Yamaguchi, MD, PhD,  Principal Investigator,  National Cardiovascular Center   

Study ID Numbers:  EAST
Last Updated:  September 9, 2005
Record first received:  September 8, 2005
ClinicalTrials.gov Identifier:  NCT00153946
Health Authority: Japan: Ministry of Health, Labor and Welfare
ClinicalTrials.gov processed this record on 2005-09-13