Acute Ischemic Stroke
Conditions
Keywords
acute ischemic stroke, edaravone dextrol, real-world study
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.
Interventions
intravenous edaravone dexborneol 37.5mg twice daily
Sponsors
Xuanwu Hospital, Beijing
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Symptomatic intracranial hemorrhage (sICH) | during hospitalization, an average of 7 days | Symptomatic intracranial hemorrhage during hospitalization |
Countries
China
Outcome results
None listed