Edaravone and Argatroban Stroke Therapy Study for Acute Ischemic Stroke

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00153946

Acronym

EAST

Enrollment

814

Registered

2005-09-12

Start date

2004-08-31

Completion date

2008-05-31

Last updated

2008-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

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

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.

Interventions

DRUGEdaravone

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Modified Rankin Scale (MRS) score	at 3 months
Symptomatic intracranial hemorrhage	for the initial 3 weeks

Secondary

Measure	Time frame
NIHSS score, JSS score, Barthel Index, modified Rankin Scale score	at various time-points
Various adverse effects	for the 3 months

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026