ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Edaravone and Argatroban Stroke Therapy Study for Acute Ischemic Stroke (EAST)

This study has been completed.

Sponsors and Collaborators: Combination Therapy for Acute Ischemic Stroke Study Group
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

Drug Information available for:   Argatroban   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:   Multicenter Randomized Open-Label Comparison Study on the Efficacy and Safety of Argatroban Monotherapy With Argatroban-Edaravone Combination Therapy

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
A: Active Comparator
The patients who are allocated to Argatroban monotherapy
Drug: Edaravone
30mg/20mL vial, twice per day, not longer than two weeks
B: Active Comparator
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, Osaka
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 Cardiovascular Center    
Principal Investigator:     Takenori Yamaguchi, MD, PhD     National 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:   National Cardiovascular Center ( Takenori Yamaguchi, M.D., President Emeritus )
Study ID Numbers:   EAST
First Received:   September 8, 2005
Last Updated:   May 12, 2008
ClinicalTrials.gov Identifier:   NCT00153946
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)  

Study placed in the following topic categories:
Thrombin
Cerebral Infarction
Stroke
Vascular Diseases
Central Nervous System Diseases
Ischemia
Brain Diseases
Cerebrovascular Disorders
Argatroban
Brain Ischemia
Brain Infarction
Infarction
Phenylmethylpyrazolone

Additional relevant MeSH terms:
Antioxidants
Anticoagulants
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Physiological Effects of Drugs
Free Radical Scavengers
Hematologic Agents
Nervous System Diseases
Platelet Aggregation Inhibitors
Cardiovascular Diseases
Protective Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 20, 2008




Links to all studies - primarily for crawlers