Edaravone Dexborneol Combining With Mechanical Thrombectomy in the Treatment of Acute Ischemic Stroke

Study Overview
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Brief Summary
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Edaravone dexborneol, comprised of 2 active ingredients, edaravone and (+)-borneol, has been developed as a novel neuroprotective agent with synergistic effects of antioxidant and anti-inflammatory in animal models. The TASTE trial (Treatment of Acute Ischemic Stroke with Edaravone Dexborneol) administered edaravone dexborneol or edaravone alone to stroke patients within 48 hours after stroke onset, finding that 90-d functional outcome was better in edaravone dexborneol group. However, the TASTE trial excluded patients undergoing reperfusion therapy (i.e., intravenous thrombolysis and mechanical thrombectomy). Therefore, the investigators aim to evaluate the efficacy of edaravone dexborneol in addition to mechanical thrombectomy in the treatment of acute ischemic stoke.

Detailed Description
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This is a prospective, non-randomized clinical trial in multiple stroke centres of China. The total sample size will be 200. Patients with anterior-circulation large artery occlusion obtaining successful recanalization after mechanical thrombectomy (MT) will be assigned into edaravone dexborneol or standard medication treatment group based on whether or not receiving edaravone dexborneol. Only patients with edaravone dexborneol initiating within 48 hours of stoke onset at 37.5 mg/dose, once every 12 hours, and continuing for more than 7 days could be enrolled as edaravone dexborneol group. Patients in standard medication treatment group must not receive edaravone dexborneol. Other neuroprotective agents are not limited to use.

Official Title
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An Observational Trial of Edaravone Dexborneol Combining With Mechanical Thrombectomy in the Treatment of Acute Ischemic Stroke

Conditions
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Stroke

Intervention / Treatment
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* Drug: Edaravone Dexborneol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients presenting with anterior circulation acute ischemic stroke Patients aged between 18-80 years. CTA or DSA verified arterial occlusion of ICA, M1 or M2. NIHSS on admission 4 - 26 Baseline CTP verified infarct core < 70 ml, penumbra > 10 ml, hypoperfusion/core > 1.8 Undergoing mechanical thrombectomy within 24 hours of stroke onset. For wake-up stroke, the onset time is determined as the midpoint of last-seen-well and discovered time Exclusion Criteria: Patients without recanalization (TICI 0,1, 2a) Pre-existing neurological disability (a score greater than 2 on the mRS) Contraindication of edaravone dexborneol

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Edaravone dexborneol group<br>Patients with edaravone dexborneol initiating within 48 hours of stoke onset at 37.5 mg/dose, once every 12 hours, and continuing for more than 7 days will be classified into this group. | Drug: Edaravone Dexborneol<br>* Edaravone dexborneol (Jiangsu Simcere Pharmaceutical, Co, Ltd) will be initiated within 48 hours of stoke onset at 37.5 mg/dose, once every 12 hours, and continuing for more than 7 days (maximum: 14 days)<br>|
| Standard medication group<br>Patients who do not recieve edaravone dexborneol will be classified into this group. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of functional independence at 90 days | Functional independence will be assessed by ratio of modefied Rankin Scale (mRS) score of 0-2 mRS: minimum value = 0, maximum value = 6, and lower scores mean a better outcome | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Growth in infarct volume (mL) | 24 hour infarct volume (mL) - 7 day infarct volume (mL) | from 24 hours to 7 days | 
| Salvaged ischemic tissue index (%) | 100%*(baseline hypoperfusion (mL) - 7 day infarction lesion (mL))/ baseline hypoperfusion (mL) | from baseline to 7 days | 
| Frequency of parenchymal hemorrhage (PH) (%) | The presence of PH is defined according the standard from ECASS-2 study thrombectomy | 24 hours | 
| Change on the National Institute of Health stroke scale (NIHSS) score from baseline to 1 day | NIHSS: minimum value = 0, maximum value = 42, and higher scores mean severer symptoms | from baseline to 1 day | 
| Change on the National Institute of Health stroke scale (NIHSS) score from 1 day to 7 day | NIHSS: minimum value = 0, maximum value = 42, and higher scores mean severer symptoms | from 1 day to 7 days | 
| Excellent recovery assessed by the ratio of modefied Rankin Scale (mRS) score of 0-1 | mRS: minimum value = 0, maximum value = 6, and lower scores mean a better outcome | 90 days | 
| Recovery assessed by modefied Rankin Scale (mRS) score | mRS: minimum value = 0, maximum value = 6, and lower scores mean a better outcome | 90 days |