Study of Compound Edaravone Injection for Treatment of Acute Ischemic Stroke

Study Overview
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Brief Summary
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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.

Official Title
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Phase Ⅲ Trial of Compound Edaravone Injection for Treatment of Acute Ischemic Stroke -- a Multi-center, Randomized, Double-blind, Parallel, Multi-doses and Active-controlled Study

Conditions
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Acute Ischemic Stroke

Intervention / Treatment
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* Drug: Compound Edaravone Injection-Low dose
* Drug: Compound Edaravone Injection-High dose
* Drug: Edaravone Injection
* Drug: Placebo injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hospitalized patients, diagnosed of ischemic stroke; Onset of stroke is less than or equal to 48 hours; There are clear signs of neurological deficit: 4≤NIHSS score≤24, and also, the sum of NIHSS score for the upper limb and the lower limb is greater than or equal to 2; Patients signed written inform consent Exclusion Criteria: Cranial CT scan finds intracranial bleeding disorders: hemorrhagic stroke, epidural hematoma, intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage; Iatrogenic stroke; Severe disturbance of consciousness: NIHSS category 1a for consciousness is greater than 1； The mRS score prior to this onset is greater than 1; Transient ischemic attack (TIA); SBP after blood pressure control is still greater than or equal to 220 mmHg, or DBP after blood pressure control is still greater than or equal to 120 mmHg; Patients with severe mental disorders and dementia; ALT or AST is greater than 2.0×ULN; Serum Creatinine (SCr) is greater than 1.5×ULN or Creatinine Clearance (CrCl) is less than 50 ml/min; Therapeutic neuroprotective agents have been applied after onset of stroke, including commercially available edaravone, nimodipine, ganglioside, citicoline, piracetam, butyl benzene peptides, Urinary Kallidinogenase; Thrombectomy or interventional therapy has been applied or planned after this onset; Patients with malignant tumors or receiving concurrent antitumor treatment; Patients with severe systemic disease, life expectancy is less than 90 days; Allergic to edaravone , taurine or related excipients; Pregnant or lactating women; Have major surgery within 4 weeks before enrollment and not recovered enough to start the study; Participated in other clinical studies within 30 days before randomization; The investigators consider the patients are not suitable for this trial.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Compound Edaravone Injection-Low dose<br> | Drug: Compound Edaravone Injection-Low dose<br>* Compound Edaravone Injection 30mg/dose (Edaravone 30mg, Taurine 600 mg), one dose every 12 hours, continue for 14 days<br>|
| Experimental: Compound Edaravone Injection-High dose<br> | Drug: Compound Edaravone Injection-High dose<br>* Compound Edaravone Injection 50mg/dose (Edaravone 50mg, Taurine 1000 mg), one dose every 12 hours, continue for 14 days<br>|
| Active Comparator: Edaravone Injection<br> | Drug: Edaravone Injection<br>* Edaravone Injection 30mg/dose, one dose every 12 hours, continue for 14 days<br>|
| Placebo Comparator: Placebo Injection<br> | Drug: Placebo injection<br>* Placebo injection, one dose every 12 hours, continue for 14 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients with mRS ≤1 on day 90 |  | day 90 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 |