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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

September 8, 2005
May 12, 2008
August 2004
March 2008   (final data collection date for primary outcome measure)
  • 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 ]
  • Modified Rankin Scale score at 3 months
  • Symptomatic intracranial hemorrhage for the initial 3 weeks
Complete list of historical versions of study NCT00153946 on ClinicalTrials.gov Archive Site
  • 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 ]
  • NIHSS score, JSS score, Barthel Index, modified Rankin Scale score at various time-points
  • Various adverse effects for the 3 months
Not Provided
Not Provided
 
Edaravone and Argatroban Stroke Therapy Study for Acute Ischemic Stroke
Multicenter Randomized Open-Label Comparison Study on the Efficacy and Safety of Argatroban Monotherapy With Argatroban-Edaravone Combination Therapy

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Stroke
Drug: Edaravone
30mg/20mL vial, twice per day, not longer than two weeks
  • Active Comparator: A
    The patients who are allocated to Argatroban monotherapy
    Intervention: Drug: Edaravone
  • Active Comparator: B
    The patients who are allocated to Edaravone-Argatroban combination therapy
    Intervention: Drug: Edaravone

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
814
May 2008
March 2008   (final data collection date for primary outcome measure)

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
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00153946
EAST
Yes
Takenori Yamaguchi, M.D., President Emeritus, National Cardiovascular Center
Combination Therapy for Acute Ischemic Stroke Study Group
Japan Cardiovascular Research Foundation
Study Chair: Takenori Yamaguchi, MD, PhD National Cerebral and Cardiovascular Center
Principal Investigator: Takenori Yamaguchi, MD, PhD National Cerebral and Cardiovascular Center
Combination Therapy for Acute Ischemic Stroke Study Group
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP