Edaravone and Argatroban Stroke Therapy Study for Acute Ischemic Stroke - Clinical Trial for Stroke | NCT00153946

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Primary Purpose

Status

Completed

Phase

Phase 4

Locations

Japan

Study Type

Interventional

Intervention

Edaravone

About this trial

This is an interventional treatment trial for Stroke focused on measuring Free Radical Scavenger, Selective Thrombin Inhibitor, Acute ischemic stroke (nonlacunar and noncardioembolic)

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

EAST Study Office c/o National Cardiovascular Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

A

B

Arm Description

The patients who are allocated to Argatroban monotherapy

The patients who are allocated to Edaravone-Argatroban combination therapy

Outcomes

Primary Outcome Measures

Modified Rankin Scale (MRS) score

Symptomatic intracranial hemorrhage

Secondary Outcome Measures

NIHSS score, JSS score, Barthel Index, modified Rankin Scale score

Various adverse effects

Full Information

NCT ID

NCT00153946

First Posted

September 8, 2005

Last Updated

May 12, 2008

Sponsor

Combination Therapy for Acute Ischemic Stroke Study Group

Collaborators

Japan Cardiovascular Research Foundation

1. Study Identification

Unique Protocol Identification Number

NCT00153946

Brief Title

Edaravone and Argatroban Stroke Therapy Study for Acute Ischemic Stroke

Acronym

EAST

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2008

Overall Recruitment Status

Completed

Study Start Date

August 2004 (undefined)

Primary Completion Date

March 2008 (Actual)

Study Completion Date

May 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Combination Therapy for Acute Ischemic Stroke Study Group

Collaborators

Japan Cardiovascular Research Foundation

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

814 (Actual)

8. Arms, Groups, and Interventions

Arm Title

A

Arm Type

Active Comparator

Arm Description

The patients who are allocated to Argatroban monotherapy

Arm Title

B

Arm Type

Active Comparator

Arm Description

The patients who are allocated to Edaravone-Argatroban combination therapy

Intervention Type

Drug

Intervention Name(s)

Edaravone

Intervention Description

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

Primary Outcome Measure Information:

Title

Modified Rankin Scale (MRS) score

Time Frame

at 3 months

Title

Symptomatic intracranial hemorrhage

Time Frame

for the initial 3 weeks

Secondary Outcome Measure Information:

Title

NIHSS score, JSS score, Barthel Index, modified Rankin Scale score

Time Frame

at various time-points

Title

Various adverse effects

Time Frame

for the 3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Takenori Yamaguchi, MD, PhD

Organizational Affiliation

National Cerebral and Cardiovascular Center, Japan

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Takenori Yamaguchi, MD, PhD

Organizational Affiliation

National Cerebral and Cardiovascular Center, Japan

Official's Role

Principal Investigator

Facility Information:

Facility Name

EAST Study Office c/o National Cardiovascular Center

City

Suita

State/Province

Osaka

ZIP/Postal Code

565-8565

Country

Japan

12. IPD Sharing Statement

Citations:

PubMed Identifier

12074843

Citation

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.

Results Reference

background

PubMed Identifier

22633681

Citation

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.

Results Reference

derived

Edaravone and Argatroban Stroke Therapy Study for Acute Ischemic Stroke (EAST)

Stroke

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial