Edaravone Dexborneol for Treatment of Acute Ischemic Stroke With Endovascular Therapy in Extended Time Windows

Study Overview
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Brief Summary
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To explore the safety and efficacy of edaravone dexborneol for patients of acute ischemic stroke received endovascular therapy in extended time windows.

Official Title
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Edaravone Dexborneol for Treatment of Acute Ischemic Stroke With Endovascular Therapy in Extended Time Windows (EXISTENT):a Prospective, Randomized, Open-label, Multi-centre Study

Conditions
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Stroke, Ischemic

Intervention / Treatment
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* Drug: Edaravone Dexborneol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 to 80 years of age; Acute ischemic stroke with National Institute of Health Stroke Scale (NIHSS) ≥ 10 and Volume of infarction on DWI <31ml or with a NIHSS ≥20 and 31ml<Volume of infarction<51ml(DWI); Patients who presented with acute ischemic stroke and a large vessel occlusion in the anterior circulation; Endovascular Therapy in 6-24 hours of stroke onset; The availability of informed consent. Exclusion Criteria: First ever stroke or mRS≤1 after previous disease; Hemorrhagic stroke: cerebral hemorrhage, subarachnoid hemorrhage; Coagulation disorders, systematic hemorrhagic tendency, thrombocytopenia Severe hepatic or renal dysfunction, increase in ALT or AST (more than 2 times of upper limit of normal value), increase in serum creatinine (more than 1.5 times of upper limit of normal value) or requiring dialysis; Severe cardiac or pulmonary disease; Patients with malignant tumor or under antineoplastic therapy with estimated lifetime less than 3 months; Pregnancy, plan to get pregnant or during lactation; Patients with contraindication or allergic to any ingredient of drugs in our study; Unsuitable for this clinical studies assessed by researcher

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Edaravone Dexborneol<br> | Drug: Edaravone Dexborneol<br>* Intravenous injections of edaravone dexborneol (37.5mg in 0·9% NaCl) BID for 7-14days.<br>|
| No Intervention: conventional therapy<br>conventional therapy of acute ischemic stroke after Endovascular Therapy based on Chinese guidelines for endovascular therapy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with modified Rankin Score 0 to 3 on day 90 |  | 90 days | 
| Proportion of symptomatic intracranial hemorrhage (sICH) |  | 48 hours | 
| mTICI grade (<2 b、≥2 b) stratified for primary outcome analysis |  | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in National Institute of Health stroke scale (NIHSS) on day 2,7,14 |  | 14 days | 
| Distribution of modified Rankin Score after the treatment |  | 90 days | 
| Change in infarct volume |  | 7 days | 
| The proportion of patients with Barthel Index (BI) score greater than or equal to 95 on day 14, 30, 90 |  | 90 days | 
| Activity of Daily Living Scale(ADL) score on day 14, 30, 90 |  | 90 days | 
| Montreal Cognitive Assessment(MoCA) score on day 14, 30, 90 |  | 90 days | 
| Serum inflammatory factors changes on day 1 and day 7 |  | 7 days | 
| Proportion of PH1 and PH2 within 48 hours after the treatment |  | 48 hours | 
| Midline shift on the CT scan |  | 7 days | 
| Proportion of death due to any cause |  | 90 days | 
| Proportion of Serious adverse events(SAE) |  | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endovascular therapy, Extended Time Windows