Improving Neuroprotective Strategy for Ischemic Stroke With Sufficient Recanalization After Thrombectomy by Edaravone Dexborneol

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 endovascular thrombectomy.

Official Title
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Improving Neuroprotective Strategy for Ischemic Stroke With Sufficient Recanalization After Thrombectomy by Edaravone Dexborneol (INSIST-ED): a Prospective, Randomized, Double Blinded, Multi-centre Study

Conditions
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Stroke, Endovascular Thrombectomy

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; Patients who presented with acute ischemic stroke and a large vessel occlusion in the anterior circulation and met the criteria of mechanical thrombectomy; Sufficient recanalization within 9 hours of stroke onset; Sufficient recanalization （TICI 2b-3）; Acute ischemic stroke with neurological baseline deficit equivalent to the National Institute of Health Stroke Scale (NIHSS) ≥ 6 before recanalization treatment; First ever stroke or mRS≤1 after previous disease The availability of informed consent. Exclusion Criteria: Acute ischemic stroke patients with insufficient recanalization（TICI < 2a） Hemorrhagic transformation (PH2) indicated by NCCT performed after the operation immediately; Hemorrhagic stroke: cerebral hemorrhage, subarachnoid hemorrhage; Coagulation disorders, systematic hemorrhagic tendency, thrombocytopenia （ <100000/mm3）; 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 hypertension (systolic blood pressure over 200mmHg or diastolic blood pressure over 110 mmHg); 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 0.9% NaCl<br>Intravenous injections of 0.9% NaCl BID for 12 ±2days. | Drug: edaravone dexborneol<br>* Intravenous injections of edaravone dexborneol (37.5mg, dissolved in 100ml saline) twice a day for 12 ±2 days.<br>* Other names: edaravone deborbeol placebo;|
| Experimental: Edaravone Dexborneol<br>Intravenous injections of edaravone dexborneol (37.5mg in 0·9% NaCl) BID for 12 ±2days. | Drug: edaravone dexborneol<br>* Intravenous injections of edaravone dexborneol (37.5mg, dissolved in 100ml saline) twice a day for 12 ±2 days.<br>* Other names: edaravone deborbeol placebo;|

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 2 | Proportion of patients with modified Rankin Score 0 to 2 | Day 90 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with modified Rankin Score 0 to 1 | Proportion of patients with modified Rankin Score 0 to 1 | Day 90 | 
| Distribution of modified Rankin Score | Distribution of modified Rankin Score after the treatment | Day 90 | 
| Changes in National Institute of Health stroke scale (NIHSS) | the minimum and maximum values of NIHSS are 42 and 0, respectively; higher NIHSS mean a worse outcome | 24 hours, 48 hours, and 2 weeks | 
| Change in infarct volume | infarct volume is determinted by CT or DWI | 1 week |