Edaravone and Argatroban Stroke Therapy Study for Acute Ischemic Stroke (EAST)
This study has been completed.
Sponsor:
Combination Therapy for Acute Ischemic Stroke Study Group
Collaborator:
Japan Cardiovascular Research Foundation
Information provided by:
Combination Therapy for Acute Ischemic Stroke Study Group
ClinicalTrials.gov Identifier:
NCT00153946
First received: September 8, 2005
Last updated: May 12, 2008
Last verified: May 2008
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Stroke |
Drug: Edaravone |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Multicenter Randomized Open-Label Comparison Study on the Efficacy and Safety of Argatroban Monotherapy With Argatroban-Edaravone Combination Therapy |
Resource links provided by NLM:
Further study details as provided by Combination Therapy for Acute Ischemic Stroke Study Group:
Primary Outcome Measures:
- Modified Rankin Scale (MRS) score [ Time Frame: at 3 months ] [ Designated as safety issue: Yes ]
- Symptomatic intracranial hemorrhage [ Time Frame: for the initial 3 weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- NIHSS score, JSS score, Barthel Index, modified Rankin Scale score [ Time Frame: at various time-points ] [ Designated as safety issue: Yes ]
- Various adverse effects [ Time Frame: for the 3 months ] [ Designated as safety issue: Yes ]
| Enrollment: | 814 |
| Study Start Date: | August 2004 |
| Study Completion Date: | May 2008 |
| Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: A
The patients who are allocated to Argatroban monotherapy
|
Drug: Edaravone
30mg/20mL vial, twice per day, not longer than two weeks
|
|
Active Comparator: B
The patients who are allocated to Edaravone-Argatroban combination therapy
|
Drug: Edaravone
30mg/20mL vial, twice per day, not longer than two weeks
|
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00153946
Locations
| Japan | |
| EAST Study Office c/o National Cardiovascular Center | |
| Suita, Osaka, Japan, 565-8565 | |
Sponsors and Collaborators
Combination Therapy for Acute Ischemic Stroke Study Group
Japan Cardiovascular Research Foundation
Investigators
| Study Chair: | Takenori Yamaguchi, MD, PhD | National Cerebral and Cardiovascular Center |
| Principal Investigator: | Takenori Yamaguchi, MD, PhD | National Cerebral and Cardiovascular Center |
More Information
Publications:
Yong-Jian Jin, Tatsuo Mima, Valerica Raicu, et al: Combined argatroban and edaravone caused additive neuroprotection against 15 min of forebrain ischemia in gerbils. Neuroscience Research 2002;43:75-79 The Edaravone Acute Brain Infarction Study Group: Effect of a novel free radical scavenger, Edaravone (MCI-186), on acute brain infarction. Randomized, placebo-controlled, double-blind study at multicenters. Cerebrovasc Dis 2003;15: 222-229
| Responsible Party: | Takenori Yamaguchi, M.D., President Emeritus, National Cardiovascular Center |
| ClinicalTrials.gov Identifier: | NCT00153946 History of Changes |
| Other Study ID Numbers: | EAST |
| Study First Received: | September 8, 2005 |
| Last Updated: | May 12, 2008 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Keywords provided by Combination Therapy for Acute Ischemic Stroke Study Group:
|
Free Radical Scavenger Selective Thrombin Inhibitor Acute ischemic stroke (nonlacunar and noncardioembolic) |
Additional relevant MeSH terms:
|
Stroke Cerebral Infarction Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Brain Infarction Brain Ischemia Argatroban Phenylmethylpyrazolone Free Radical Scavengers |
Antithrombins Serine Proteinase Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anticoagulants Hematologic Agents Therapeutic Uses Platelet Aggregation Inhibitors Antioxidants Protective Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 18, 2013