Effectiveness and Safety of Edaravone Dexborneol in Acute Ischemic Stroke

Acute Ischemic Stroke Clinical Trial

— EXPAND  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05644223
• Other study ID #: SMA-AIS-008
• Status: Recruiting
• Start date: January 1, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: August 2023
• Source: Xuanwu Hospital, Beijing
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4750
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Drug:
• edaravone dexborneol
intravenous edaravone dexborneol 37.5mg twice daily

Locations

Country	Name	City	State
China	Junwei Hao	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Xuanwu Hospital, Beijing

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Symptomatic intracranial hemorrhage (sICH)	Symptomatic intracranial hemorrhage during hospitalization	during hospitalization, an average of 7 days
Other	Intracranial hemorrhage during hospitalization (ICH)	Intracranial hemorrhage during hospitalization, an average of 7 days	during hospitalization
Other	All-cause death	All-cause mortality at 90±7 days	90±7 days
Other	Adverse events	Adverse events during the use of edaravone dexborneol	during the use of edaravone dexborneol
Primary	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	Proportion of patients with mRS 0-2	Proportion of patients with mRS score of 0 to 2 at 90±7 days	90±7 days
Secondary	Distribution of mRS score	Distribution of mRS score at 90±7 days	90±7 days
Secondary	Neurological functional change	The change of NIHSS score at discharge compared with the baseline NIHSS score	at discharge, an average of 7 days
Secondary	Quality of Life (EQ-5D-5L) at 90 days	The value of EQ-5D-5L at 90±7 days	90±7 days