Edaravone and Argatroban Stroke Therapy Study for Acute Ischemic Stroke - Full Text View

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

This study has been completed.

First Received on September 8, 2005. Last Updated on May 12, 2008 History of Changes

Sponsor:	Combination Therapy for Acute Ischemic Stroke Study Group
Collaborator:	Japan Cardiovascular Research Foundation
Information provided by:	Combination Therapy for Acute Ischemic Stroke Study Group
ClinicalTrials.gov Identifier:	NCT00153946

Purpose

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
Stroke	Drug: Edaravone	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

Drug Information available for: Argatroban

U.S. FDA Resources

Further study details as provided by Combination Therapy for Acute Ischemic Stroke Study Group:

Primary Outcome Measures:

Modified Rankin Scale (MRS) score [ Time Frame: at 3 months ] [ Designated as safety issue: Yes ]
Symptomatic intracranial hemorrhage [ Time Frame: for the initial 3 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

NIHSS score, JSS score, Barthel Index, modified Rankin Scale score [ Time Frame: at various time-points ] [ Designated as safety issue: Yes ]
Various adverse effects [ Time Frame: for the 3 months ] [ Designated as safety issue: Yes ]

Enrollment:	814
Study Start Date:	August 2004
Study Completion Date:	May 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00153946

Locations

Japan
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

More Information

Publications:

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

Responsible Party:	Takenori Yamaguchi, M.D., President Emeritus, National Cardiovascular Center
ClinicalTrials.gov Identifier:	NCT00153946 History of Changes
Other Study ID Numbers:	EAST
Study First Received:	September 8, 2005
Last Updated:	May 12, 2008
Health Authority:	Japan: Ministry of Health, Labor and Welfare

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:

Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Argatroban
Phenylmethylpyrazolone
Free Radical Scavengers

Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anticoagulants
Hematologic Agents
Therapeutic Uses
Platelet Aggregation Inhibitors
Antioxidants
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 12, 2012