EXPAND: Effectiveness and Safety of Edaravone Dexborneol in Acute Ischemic Stroke
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
Arms and Interventions
| Arm | 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 |
Outcome Measures
Primary Outcome Measures
- 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
- Proportion of patients with mRS 0-2 [90±7 days]
Proportion of patients with mRS score of 0 to 2 at 90±7 days
- Distribution of mRS score [90±7 days]
Distribution of mRS score 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
- Patient reported outcome (Stroke Impact Scale-16) [90±7 days]
The score of SIS-16 (on a scale from 16 to 80, with higher scores indicating better outcome) at 90±7 days
Other Outcome Measures
- Symptomatic intracranial hemorrhage (sICH) [during hospitalization, an average of 7 days]
Symptomatic intracranial hemorrhage during hospitalization
- Intracranial hemorrhage during hospitalization (ICH) [during hospitalization]
Intracranial hemorrhage during hospitalization, an average of 7 days
- All-cause death [90±7 days]
All-cause mortality at 90±7 days
- Adverse events [during the use of edaravone dexborneol]
Adverse events during the use of edaravone dexborneol
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age≥18 years old；
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Clinically diagnosed as acute ischemic stroke；
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Time from symptom onset to admission≤14 days (symptom onset time is defined as last known well time)；
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Pre-stroke mRS ≤1；
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Have been informed of the content of the informed consent form and agree to participate.
Exclusion Criteria:
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Acute intracranial hemorrhagic diseases confirmed by images: parenchymal hemorrhage, epidural hematoma, subdural hematoma, ventricular hemorrhage, subarachnoid hemorrhage, etc.
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Patients who are pregnant or lactating and who are planned to become pregnant within 90 days;
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Patients with severe renal failure (eGFR<30ml/min);
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Patients with concurrent malignancy or severe systemic disease with an estimated survival of less than 90 days;
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Patients with severe mental disorders or unable to complete the informed consent and follow-up due to dementia;
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Patients who are judged unsuitable for participation in the study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Junwei Hao | Beijing | China | 100053 |
Sponsors and Collaborators
- Xuanwu Hospital, Beijing
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SMA-AIS-008