Effectiveness and Safety of Edaravone Dexborneol in Acute Ischemic Stroke (EXPAND)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Ischemic Stroke
• Intervention / Treatment: Drug: edaravone dexborneol

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 Type: Observational
• Enrollment (Estimated): 4750

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100053
    • Recruiting
    • Junwei Hao
    • Contact: Junwei Hao, MD; Phone Number: 01083198277; Email: haojunwei@vip.163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients who aged more than 18 years old and diagnosed as acute ischemic stroke (time from symptom onset to admission ≤ 14 days) with pre-stroke mRS ≤1 can be enrolled in this study.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Exposet group; intravenous edaravone dexborneol 37.5mg twice daily	Drug: edaravone dexborneol; intravenous edaravone dexborneol 37.5mg twice daily
Non-exposed group; standard treatment at the discretion of local clinicians

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptomatic intracranial hemorrhage (sICH)	Symptomatic intracranial hemorrhage during hospitalization	during hospitalization, an average of 7 days
Intracranial hemorrhage during hospitalization (ICH)	Intracranial hemorrhage during hospitalization, an average of 7 days	during hospitalization
All-cause death	All-cause mortality at 90±7 days	90±7 days
Adverse events	Adverse events during the use of edaravone dexborneol	during the use of edaravone dexborneol

Collaborators and Investigators

• Sponsor: Xuanwu Hospital, Beijing

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: November 21, 2022
• First Submitted That Met QC Criteria: November 30, 2022
• First Posted (Actual): December 9, 2022

Study Record Updates

• Last Update Posted (Actual): August 31, 2023
• Last Update Submitted That Met QC Criteria: August 28, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: acute ischemic stroke; edaravone dextrol; real-world study
• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Infarction; Brain Infarction; Stroke; Ischemic Stroke; Ischemia; Cerebral Infarction; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Neuroprotective Agents; Protective Agents; Antioxidants; Free Radical Scavengers; Edaravone
• Other Study ID Numbers: SMA-AIS-008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No