Effectiveness and Safety of Edaravone Dexborneol in Acute Ischemic Stroke

Study Overview
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Brief Summary
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This study is a multicenter, prospective, cohort study to observe the clinical efficacy and safety of edaravone dextrol in patients with acute ischemic stroke in a real-world setting.

Detailed Description
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The study lasts a total of 90 days and includes three phases: screening, treatment, and follow-up. Treatment period: patients are divided into exposure group and non-exposed group based on the use of edaravone dextrol after ischemic stroke. The exposure group: edaravone dextrol is used according to reference to clinical practice, without specific restrictions. The non-exposed group: edaravone dextrol is not used, and concomitant therapy is at the clinician's discretion. Follow-up period: All patients continue to be followed up to 90 days after stroke onset.

Official Title
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Effectiveness and Safety of Edaravone Dexborneol in Acute Ischemic Stroke: a Multicenter, Prospective, Patient-centered, Real-world Cohort Study

Conditions
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Acute Ischemic Stroke

Intervention / Treatment
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* Drug: edaravone dexborneol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age≥18 years old； Clinically diagnosed as acute ischemic stroke； Time from symptom onset to admission≤14 days (symptom onset time is defined as last known well time)； Pre-stroke mRS ≤1； Have been informed of the content of the informed consent form and agree to participate. Exclusion Criteria: Acute intracranial hemorrhagic diseases confirmed by images: parenchymal hemorrhage, epidural hematoma, subdural hematoma, ventricular hemorrhage, subarachnoid hemorrhage, etc. Patients who are pregnant or lactating and who are planned to become pregnant within 90 days; Patients with severe renal failure (eGFR<30ml/min); Patients with concurrent malignancy or severe systemic disease with an estimated survival of less than 90 days; Patients with severe mental disorders or unable to complete the informed consent and follow-up due to dementia; Patients who are judged unsuitable for participation in the study.

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| Exposet group<br>intravenous edaravone dexborneol 37.5mg twice daily | Drug: edaravone dexborneol<br>* intravenous edaravone dexborneol 37.5mg twice daily<br>|
| Non-exposed group<br>standard treatment at the discretion of local clinicians | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with modified Rankin Scale (mRS) score 0-1 | Proportion of patients with modified Rankin Scale (mRS) score (on a scale from 0 to 6, with higher scores indicating greater disability) of 0 to 1 at 90±7 days | 90±7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with mRS 0-2 | Proportion of patients with mRS score of 0 to 2 at 90±7 days | 90±7 days | 
| Distribution of mRS score | Distribution of mRS score at 90±7 days | 90±7 days | 
| Neurological functional change | The change of NIHSS score at discharge compared with the baseline NIHSS score | at discharge, an average of 7 days | 
| Quality of Life (EQ-5D-5L) at 90 days | The value of EQ-5D-5L at 90±7 days | 90±7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute ischemic stroke, edaravone dextrol, real-world study