Thrombolysis Combined With Edaravone Dexborneol on Hemorrhagic Transformation for Acute Ischemic Stroke

Study Overview
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Brief Summary
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To explore the safety and efficacy of edaravone dexborneol for the treatment of acute ischemic stroke patients who received thrombolysis.

Official Title
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Effect of Thrombolysis Combined With Edaravone Dexborneol for Acute Ischemic Stroke Patients: a Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial

Conditions
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Stroke, Ischemic

Intervention / Treatment
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* Drug: Edaravone Dexborneol
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Acute ischemic stroke; 18 to 80 years of age; There are clear signs of neurological deficit: 8≤NIHSS score≤24; Received alteplase thrombolysis therapy within 4.5 hours after onset; Patients signed written inform consent Exclusion Criteria: Patients need endovascular therapy or bridge therapy; Cranial CT scan finds intracranial bleeding disorders: hemorrhagic stroke, epidural hematoma, intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage; Severe head trauma or stroke, intracranial tumor or large intracranial aneurysm within 3 months; Intracranial or intraspinal surgery within 3 months; Active visceral hemorrhage Major surgery within 2 weeks or arterial puncture within 1 week that is difficult to compress the hemostatic site; Unknown onset time; Rapid improvement of symptoms or mild symptoms before thrombolysis therapy; A platelet count below 100,000/mm3 indicates a propensity for acute bleeding; Therapeutic neuroprotective agents have been applied after onset of stroke, including commercially available edaravone, nimodipine, ganglioside, citicoline, piracetam, butyl benzene peptides, Urinary Kallidinogenase; Patients with severe mental disorders and dementia; ALT or AST is greater than 2.0×ULN or previously known liver diseases, such as acute hepatitis, chronic active hepatitis, liver cirrhosis; Serum Creatinine (SCr) is greater than 1.5×ULN, Creatinine Clearance (CrCl) is less than 50 ml/min or previously known severe renal diseases; Patients with malignant tumors or severe systemic disease; allergic to edaravone , (+)-Borneol or related excipients; Pregnant or lactating women; Have major surgery within 4 weeks before enrollment; Participated in other clinical studies within 30 days before randomization; or participating in other clinical trials at present; 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Edaravone<br>Edaravone Dexborneol injection | Drug: Edaravone Dexborneol<br>* Edaravone Dexborneol 37.5 mg (containing Edaravone 30 mg and Dexborneol 7.5 mg), BID, 14 days, addition to thrombolysis<br>|
| Placebo Comparator: Placebo<br>Edaravone Dexborneol matching injection | Drug: Placebo<br>* Edaravone Dexborneol matching injection, addition to thrombolysis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of symptomatic intracranial hemorrhage |  | 36-48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of symptomatic intracranial hemorrhage |  | 7 days | 
| The proportion of intracranial hemorrhage |  | 36-48 hours, 7 days | 
| The proportion of Participants With modified Rankin Scale (mRS) Score 0 to 1 |  | 90 days | 
| The change in the NIH stroke scale (NIHSS) from the baseline |  | 36-48 hours, 7, 14 and 90 days | 
| The proportion of Participants With Barthel Index (BI) score greater than or equal to 95 |  | 14 and 90 days | 
| Vascular recanalization |  | 36-48 hours | 
| Blood Brain Barrier Permeability |  | 36-48 hours | 
| Proportion of Encephaledema |  | 36-48 hours | 
| Proportion of Death |  | 90 days |