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Edaravone and Argatroban Stroke Therapy Study for Acute Ischemic Stroke (EAST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00153946
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : May 14, 2008
Japan Cardiovascular Research Foundation
Information provided by:
Combination Therapy for Acute Ischemic Stroke Study Group

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

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Study Type : Interventional  (Clinical Trial)
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 : August 2004
Actual Primary Completion Date : March 2008
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Modified Rankin Scale (MRS) score [ Time Frame: at 3 months ]
  2. Symptomatic intracranial hemorrhage [ Time Frame: for the initial 3 weeks ]

Secondary Outcome Measures :
  1. NIHSS score, JSS score, Barthel Index, modified Rankin Scale score [ Time Frame: at various time-points ]
  2. Various adverse effects [ Time Frame: for the 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00153946

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

Yong-Jian Jin, Tatsuo Mima, Valerica Raicu, et al: Combined argatroban and edaravone caused additive neuroprotection against 15 min of forebrain ischemia in gerbils. Neuroscience Research 2002;43:75-79 The Edaravone Acute Brain Infarction Study Group: Effect of a novel free radical scavenger, Edaravone (MCI-186), on acute brain infarction. Randomized, placebo-controlled, double-blind study at multicenters. Cerebrovasc Dis 2003;15: 222-229

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Takenori Yamaguchi, M.D., President Emeritus, National Cardiovascular Center Identifier: NCT00153946    
Other Study ID Numbers: EAST
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: May 14, 2008
Last Verified: May 2008
Keywords provided by Combination Therapy for Acute Ischemic Stroke Study Group:
Free Radical Scavenger
Selective Thrombin Inhibitor
Acute ischemic stroke (nonlacunar and noncardioembolic)
Additional relevant MeSH terms:
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Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs