Edaravone and Argatroban Stroke Therapy Study for Acute Ischemic Stroke

Stroke Clinical Trial

— EAST  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00153946
• Other study ID #: EAST
• Status: Completed
• Phase: Phase 4
• First received: September 8, 2005
• Last updated: May 12, 2008
• Start date: August 2004
• Est. completion date: May 2008

Study information

• Verified date: May 2008
• Source: Combination Therapy for Acute Ischemic Stroke Study Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 814
• Est. completion date: May 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

Drug:
• Edaravone
30mg/20mL vial, twice per day, not longer than two weeks

Locations

Country	Name	City	State
Japan	EAST Study Office c/o National Cardiovascular Center	Suita	Osaka

Sponsors (2)

Lead Sponsor	Collaborator
Combination Therapy for Acute Ischemic Stroke Study Group	Japan Cardiovascular Research Foundation

Country where clinical trial is conducted

Japan, 

References & Publications (1)

Jin YJ, Mima T, Raicu V, Park KC, Shimizu K. Combined argatroban and edaravone caused additive neuroprotection against 15 min of forebrain ischemia in gerbils. Neurosci Res. 2002 May;43(1):75-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified Rankin Scale (MRS) score		at 3 months	Yes
Primary	Symptomatic intracranial hemorrhage		for the initial 3 weeks	Yes
Secondary	NIHSS score, JSS score, Barthel Index, modified Rankin Scale score		at various time-points	Yes
Secondary	Various adverse effects		for the 3 months	Yes