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Edaravone and Argatroban Stroke Therapy Study for Acute Ischemic Stroke

NCT ID: NCT00153946

Last Updated: 2008-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

814 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-31

Study Completion Date

2008-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Stroke

Keywords

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Free Radical Scavenger Selective Thrombin Inhibitor Acute ischemic stroke (nonlacunar and noncardioembolic)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

The patients who are allocated to Argatroban monotherapy

Group Type ACTIVE_COMPARATOR

Edaravone

Intervention Type DRUG

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

B

The patients who are allocated to Edaravone-Argatroban combination therapy

Group Type ACTIVE_COMPARATOR

Edaravone

Intervention Type DRUG

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

Interventions

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Edaravone

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Japan Cardiovascular Research Foundation

OTHER

Sponsor Role collaborator

Combination Therapy for Acute Ischemic Stroke Study Group

OTHER

Sponsor Role lead

Responsible Party

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National Cardiovascular Center

Principal Investigators

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Takenori Yamaguchi, MD, PhD

Role: STUDY_CHAIR

National Cerebral and Cardiovascular Center, Japan

Takenori Yamaguchi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

National Cerebral and Cardiovascular Center, Japan

Locations

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EAST Study Office c/o National Cardiovascular Center

Suita, Osaka, Japan

Site Status

Countries

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Japan

References

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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. doi: 10.1016/s0168-0102(02)00019-6.

Reference Type BACKGROUND
PMID: 12074843 (View on PubMed)

Kumagai N, Origasa H, Nagao T, Takekawa H, Okuhara Y, Yamaguchi T. Prognostic significance of smoking in patients with acute ischemic stroke within 3 months of onset. J Stroke Cerebrovasc Dis. 2013 Aug;22(6):792-8. doi: 10.1016/j.jstrokecerebrovasdis.2012.04.010. Epub 2012 May 24.

Reference Type DERIVED
PMID: 22633681 (View on PubMed)

Other Identifiers

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EAST

Identifier Type: -

Identifier Source: org_study_id