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| Name | Class |
|---|---|
| Japan Cardiovascular Research Foundation | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator | The patients who are allocated to Argatroban monotherapy |
|
| B | Active Comparator | The patients who are allocated to Edaravone-Argatroban combination therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Edaravone | Drug | 30mg/20mL vial, twice per day, not longer than two weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Modified Rankin Scale (MRS) score | at 3 months | |
| Symptomatic intracranial hemorrhage | for the initial 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| NIHSS score, JSS score, Barthel Index, modified Rankin Scale score | at various time-points | |
| Various adverse effects | for the 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Takenori Yamaguchi, MD, PhD | National Cerebral and Cardiovascular Center, Japan | Study Chair |
| Takenori Yamaguchi, MD, PhD | National Cerebral and Cardiovascular Center, Japan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| EAST Study Office c/o National Cardiovascular Center | Suita | Osaka | 565-8565 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12074843 | Background | 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. | |
| 22633681 | Derived | 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. |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000077553 | Edaravone |
| ID | Term |
|---|---|
| D000983 | Antipyrine |
| D047069 | Pyrazolones |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |