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The primary objective of the study is to confirm the efficacy of compound Edaravone Injection via intravenous infusion every 12 hours in the patients with Acute Ischemic Stroke(AIS) in a double-blind, active-controlled manner. The study is also to examine the safety of compound Edaravone Injection for the AIS patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Compound Edaravone | Experimental | Compound Edaravone Injection 37.5mg/dose (Edaravone 30mg, (+)-Borneol 7.5mg), one dose every 12 hours, continue for 14 days |
|
| Edaravone | Active Comparator | Edaravone Injection 30 mg/dose, one dose every 12 hours, continues for 14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Compound Edaravone Injection | Drug |
| ||
| Edaravone Injection |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of patients with mRS ≤1 on day 90 | day 90 |
| Measure | Description | Time Frame |
|---|---|---|
| mRS score on day 90 | day 90 | |
| Changes of NIHSS score from baseline on day 14 | day 14 | |
| The proportion of patients with NIHSS score 0-1 (including motor function) on day 14, 30, 90 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yongjun Wang, MD | Beijing Tiantan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China-Japan Friendship Hospital | Beijing | Beijing Municipality | 100029 | China | ||
| Navy General Hospital of The Chinese PLA |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33588596 | Derived | Xu J, Wang A, Meng X, Yalkun G, Xu A, Gao Z, Chen H, Ji Y, Xu J, Geng D, Zhu R, Liu B, Dong A, Mu H, Lu Z, Li S, Zheng H, Chen X, Wang Y, Zhao X, Wang Y; TASTE Trial Investigatorsdagger. Edaravone Dexborneol Versus Edaravone Alone for the Treatment of Acute Ischemic Stroke: A Phase III, Randomized, Double-Blind, Comparative Trial. Stroke. 2021 Mar;52(3):772-780. doi: 10.1161/STROKEAHA.120.031197. Epub 2021 Feb 16. |
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|
| day 14, 30, 90 |
| The proportion of patients with Barthel Index (BI) score greater than or equal to 95 on day 14, 30, 90 | day 14, 30, 90 |
| Montreal Cognitive Assessment(MoCA) score on day 14, 30, 90 | day 14, 30, 90 |
| Stroke Impact Scale (SIS) score on day 90 | day 90 |
| Beijing |
| Beijing Municipality |
| 100048 |
| China |
| Beijing Tian Tan Hospital, Capital Medical University | Beijing | Beijing Municipality | 100050 | China |
| The First Affiliated Hospital of Fujian Medical University | Fuzhou | Fujian | 350005 | China |
| Nanfang Hospital of Southern Medical University | Guangzhou | Guangdong | 510515 | China |
| The First Affiliated Hospital of Jinan University | Guangzhou | Guangdong | 510630 | China |
| Shenzhen People's Hospital | Shenzhen | Guangdong | 518020 | China |
| Peking University Shenzhen Hospital | Shenzhen | Guangdong | 518036 | China |
| Affiliated Hospital of Guilin Medical University | Guilin | Guangxi | 541001 | China |
| Liuzhou Worker's Hospital | Liuzhou | Guangxi | 545005 | China |
| Nanning Second People's Hospital | Nanning | Guangxi | 530031 | China |
| The Affiliated Hospital of Guizhou Medical University | Guiyang | Guizhou | 550004 | China |
| Cangzhou Central Hospital | Cangzhou | Hebei | 061000 | China |
| The Second Affiliated Hospital of Haerbin Medical University | Haerbin | Heilongjiang | 150001 | China |
| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | 450052 | China |
| Hunan Provincial People's Hospital | Changsha | Hunan | 410005 | China |
| The First Affiliated Hospital of University of South China | Hengyang | Hunan | 421001 | China |
| The First Affiliated Hospital of Baotou Medical College | Baotou | Inner Mongolia | 014010 | China |
| The Third Affiliated Hospital of Inner Mongolia Medical University | Baotou | Inner Mongolia | 014010 | China |
| Central Hospital of Baotou | Baotou | Inner Mongolia | 014040 | China |
| Inner Mongolia Autonomous Region People's Hospital | Hohhot | Inner Mongolia | 010017 | China |
| Affiliated Hospital of Inner Mongolia Medical University | Hohhot | Inner Mongolia | 010050 | China |
| Huai'an First Affiliated Hospital of Nanjing Medical University | Huai'an | Jiangsu | 223300 | China |
| Lianyungang First People's Hospital | Lianyungang | Jiangsu | 222002 | China |
| Nanjing First Hospital | Nanjing | Jiangsu | 210006 | China |
| Zhongda Hospital,Southeast University | Nanjing | Jiangsu | 210009 | China |
| The Second Affiliated Hospital of Nanjing Medical University | Nanjing | Jiangsu | 210011 | China |
| Nanjing Brain Hospital | Nanjing | Jiangsu | 210029 | China |
| The Affiliated Hospital of Xuzhou Medical College | Xuzhou | Jiangsu | 221006 | China |
| Northern Jiangsu People's Hospital | Yangzhou | Jiangsu | 225001 | China |
| Yangzhou No.1 People's Hospital | Yangzhou | Jiangsu | 225001 | China |
| The Second Hospital of Jilin University | Changchun | Jilin | 130041 | China |
| The Forth Hospital of Jilin University | Siping | Jilin | 130011 | China |
| Siping Central Hospital | Siping | Jilin | 136000 | China |
| The General Hospital of Shenyang Military, Chinese PLA | Shenyang | Liaoning | 110016 | China |
| The Sceond Hospital of Shandong University | Jinan | Shandong | 250033 | China |
| Liaocheng People's Hospital | Liaocheng | Shandong | 252000 | China |
| Qingdao Municipal Hospital | Qingdao | Shandong | 266011 | China |
| Shanghai Changzheng Hospital | Shanghai | Shanghai Municipality | 200003 | China |
| Yangpu Hospital, Tongji University | Shanghai | Shanghai Municipality | 200090 | China |
| The Second Affiliated Hospital of Shanxi Medical University | Taiyuan | Shanxi | 030001 | China |
| West China Hospital, Sichuan University | Chengdu | Sichuan | 610041 | China |
| Tianjin People's Hospital | Tianjin | Tianjin Municipality | 300000 | China |
| Tianjin Medical University General Hospital | Tianjin | Tianjin Municipality | 300052 | China |
| Tianjin Huanhu Hospital | Tianjin | Tianjin Municipality | 300060 | China |
| The Second Hospital of Tianjin Medical University | Tianjin | Tianjin Municipality | 300211 | China |
| Lishui People's Hospital | Lishui | Zhejiang | 323000 | China |
| The First Affiliated Hospital of Wenzhou Medical University | Wenzhou | Zhejiang | 325000 | China |
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000077553 | Edaravone |
| ID | Term |
|---|---|
| D000983 | Antipyrine |
| D047069 | Pyrazolones |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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