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

This study has been completed.
Sponsor:
Collaborator:
Japan Cardiovascular Research Foundation
Information provided by:
Combination Therapy for Acute Ischemic Stroke Study Group
ClinicalTrials.gov Identifier:
NCT00153946
First received: September 8, 2005
Last updated: May 12, 2008
Last verified: May 2008
  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 4

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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:
Cerebral Infarction
Stroke
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases
Argatroban
Phenylmethylpyrazolone
Anticoagulants
Antioxidants
Antithrombins
Enzyme Inhibitors
Free Radical Scavengers
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Protease Inhibitors
Protective Agents
Serine Proteinase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014