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Strategic realignment of sponsors.
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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 Injection-Low dose | Experimental |
| |
| Compound Edaravone Injection-High dose | Experimental |
| |
| Edaravone Injection | Active Comparator |
| |
| Placebo Injection | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Compound Edaravone Injection-Low dose | Drug | Compound Edaravone Injection 30mg/dose (Edaravone 30mg, Taurine 600 mg), one dose every 12 hours, continue for 14 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of patients with mRS ≤1 on day 90 | day 90 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of NIHSS score from baseline on day 14 | day 14 | |
| The proportion of patients with mRS ≤2 on day 90 | day 90 | |
| 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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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tiantan Hospital,Capital Medical University | Beijing | China |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central 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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| Compound Edaravone Injection-High dose | Drug | Compound Edaravone Injection 50mg/dose (Edaravone 50mg, Taurine 1000 mg), one dose every 12 hours, continue for 14 days |
|
| Edaravone Injection | Drug | Edaravone Injection 30mg/dose, one dose every 12 hours, continue for 14 days |
|
| Placebo injection | Drug | Placebo injection, one dose every 12 hours, continue for 14 days |
|
| day 14, 30, 90 |
| The proportion of patients with ADL-BI ≥95 on day 14, 30, 90 | day 14, 30, 90 |
| EQ-5D score on day 90 | day 90 |
| Ordinal Distribution of mRS on day 90 | day 90 |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |