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Completed

NCT Number: NCT00153946

Edaravone and Argatroban Stroke Therapy Study for Acute Ischemic Stroke

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

EAST Study Office c/o National Cardiovascular Center

Suita, Osaka, 565-8565, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Edaravone

Drug

30mg/20mL vial, twice per day, not longer than two weeks

Primary outcomes

  1. Modified Rankin Scale (MRS) score

    Time frame: at 3 months

  2. Symptomatic intracranial hemorrhage

    Time frame: for the initial 3 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Combination Therapy for Acute Ischemic Stroke Study Group

Other

Collaborators

  • Japan Cardiovascular Research Foundation

Registry information

Official study title

Multicenter Randomized Open-Label Comparison Study on the Efficacy and Safety of Argatroban Monotherapy With Argatroban-Edaravone Combination Therapy

Acronym: EAST

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
Sep 12, 2005
Registry last updated
May 14, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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