EAST: Edaravone and Argatroban Stroke Therapy Study for Acute Ischemic Stroke

Sponsor

Combination Therapy for Acute Ischemic Stroke Study Group (Other)

Overall Status

Completed

CT.gov ID

NCT00153946

Collaborator

Japan Cardiovascular Research Foundation (Other)

814

Enrollment

Location

Arms

Duration (Months)

18.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Stroke	Drug: Edaravone	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

814 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Multicenter Randomized Open-Label Comparison Study on the Efficacy and Safety of Argatroban Monotherapy With Argatroban-Edaravone Combination Therapy

Study Start Date :

Aug 1, 2004

Actual Primary Completion Date :

Mar 1, 2008

Actual Study Completion Date :

May 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: A The patients who are allocated to Argatroban monotherapy	Drug: Edaravone 30mg/20mL vial, twice per day, not longer than two weeks
Active Comparator: B The patients who are allocated to Edaravone-Argatroban combination therapy	Drug: Edaravone 30mg/20mL vial, twice per day, not longer than two weeks

Arm

Intervention/Treatment

Active Comparator: A

The patients who are allocated to Argatroban monotherapy

Drug: Edaravone

30mg/20mL vial, twice per day, not longer than two weeks

Active Comparator: B

The patients who are allocated to Edaravone-Argatroban combination therapy

Drug: Edaravone

30mg/20mL vial, twice per day, not longer than two weeks

Outcome Measures

Primary Outcome Measures

Modified Rankin Scale (MRS) score [at 3 months]
Symptomatic intracranial hemorrhage [for the initial 3 weeks]

Secondary Outcome Measures

NIHSS score, JSS score, Barthel Index, modified Rankin Scale score [at various time-points]
Various adverse effects [for the 3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 on 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, or antiplatelet except for aspirin before enrollment
Intravascular surgery, surgical operation, hyperbaric oxygen therapy, or hypothermia therapy before enrollment
Serum creatinine >1.5 mg/dL
Severe hepatic or cardiac disorders, infectious disorders, dehydration, etc.
Neoplasm
Pregnancy
Hypersensitivity to test drugs

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	EAST Study Office c/o National Cardiovascular Center	Suita	Osaka	Japan	565-8565

Sponsors and Collaborators

Combination Therapy for Acute Ischemic Stroke Study Group
Japan Cardiovascular Research Foundation

Investigators

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