Effectiveness and Safety of Edaravone Dexborneol in Acute Ischemic Stroke

Recruiting

• Conditions: Acute Ischemic Stroke
• Interventions: Drug: edaravone dexborneol

• Registration Number: NCT05644223
• Lead Sponsor: Xuanwu Hospital, Beijing

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2022-11-21
• Study First Submitted QC: 2022-11-30
• Study First Posted: 2022-12-09
• Study Start: 2023-01-01
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-28
• Last Update Posted: 2023-08-31
• Primary Completion: 2024-06-30
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 4750

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Exposet group	edaravone dexborneol	intravenous edaravone dexborneol 37.5mg twice daily

Primary Outcome Measures

Name	Time	Method
Proportion of patients with modified Rankin Scale (mRS) score 0-1	90±7 days	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Junwei Hao; 🇨🇳 Beijing, China