Effectiveness and Safety of Edaravone Dexborneol in Acute Ischemic Stroke

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

4750 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-01

Study Completion Date

2024-06-30

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.

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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.

Conditions

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Acute Ischemic Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Exposet group

intravenous edaravone dexborneol 37.5mg twice daily

edaravone dexborneol

Intervention Type DRUG

intravenous edaravone dexborneol 37.5mg twice daily

Non-exposed group

standard treatment at the discretion of local clinicians

No interventions assigned to this group

Interventions

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edaravone dexborneol

intravenous edaravone dexborneol 37.5mg twice daily

Intervention Type DRUG

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No