Status:
COMPLETED
Edaravone and Argatroban Stroke Therapy Study for Acute Ischemic Stroke
Lead Sponsor:
Combination Therapy for Acute Ischemic Stroke Study Group
Collaborating Sponsors:
Japan Cardiovascular Research Foundation
Conditions:
Stroke
Eligibility:
All Genders
20+ years
Phase:
PHASE4
Brief Summary
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 be...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
814 Patients enrolled
Trial Details
Trial ID
NCT00153946
Start Date
August 1 2004
End Date
May 1 2008
Last Update
May 14 2008
Active Locations (1)
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1
EAST Study Office c/o National Cardiovascular Center
Suita, Osaka, Japan, 565-8565