NCT00153946

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
814

participants targeted

Target at P75+ for phase_4 stroke

Timeline
Completed

Started Aug 2004

Typical duration for phase_4 stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2004

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

May 14, 2008

Status Verified

May 1, 2008

Enrollment Period

3.6 years

First QC Date

September 8, 2005

Last Update Submit

May 12, 2008

Conditions

Stroke

Keywords

Free Radical ScavengerSelective Thrombin InhibitorAcute ischemic stroke (nonlacunar and noncardioembolic)

Outcome Measures

Primary Outcomes (2)

  • Modified Rankin Scale (MRS) score

    at 3 months

  • Symptomatic intracranial hemorrhage

    for the initial 3 weeks

Secondary Outcomes (2)

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

    at various time-points

  • Various adverse effects

    for the 3 months

Study Arms (2)

A

ACTIVE COMPARATOR

The patients who are allocated to Argatroban monotherapy

Drug: Edaravone

B

ACTIVE COMPARATOR

The patients who are allocated to Edaravone-Argatroban combination therapy

Drug: Edaravone

Interventions

EdaravoneDRUG

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

AB

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

EAST Study Office c/o National Cardiovascular Center

Suita, Osaka, 565-8565, Japan

Location

Related Publications (2)

  • 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.

    PMID: 12074843BACKGROUND

  • 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.

    PMID: 22633681DERIVED

MeSH Terms

Conditions

StrokeIschemic Stroke

Interventions

Edaravone

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

AntipyrinePyrazolonesPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Takenori Yamaguchi, MD, PhD

    National Cerebral and Cardiovascular Center, Japan

    STUDY CHAIR

  • Takenori Yamaguchi, MD, PhD

    National Cerebral and Cardiovascular Center, Japan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

August 1, 2004

Primary Completion

March 1, 2008

Study Completion

May 1, 2008

Last Updated

May 14, 2008

Record last verified: 2008-05

Locations

JP(1)