Observing the effects of edaravone dexborneol in patients with acute ischemic stroke
Effectiveness and Safety of Edaravone Dexborneol in Acute Ischemic Stroke: a Multicenter, Prospective, Patient-centered, Real-world Cohort Study
This study is testing if a new treatment called edaravone dexborneol can help people who have had an acute ischemic stroke feel better compared to standard care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 4750 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Xuanwu Hospital, Beijing Academic / other |
| Locations | 1 site (Beijing) |
| Trial ID | NCT05644223 on ClinicalTrials.gov |
What this trial studies
This multicenter, prospective cohort study aims to evaluate the clinical efficacy and safety of edaravone dexborneol in patients diagnosed with acute ischemic stroke. The study involves a 90-day period divided into three phases: screening, treatment, and follow-up. Patients will be categorized into an exposure group receiving edaravone dexborneol and a non-exposed group receiving standard care, with follow-up assessments conducted up to 90 days post-stroke onset to monitor outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 years and older who have been clinically diagnosed with acute ischemic stroke within 14 days of symptom onset.
Not a fit: Patients with acute intracranial hemorrhagic diseases, severe renal failure, or those with severe mental disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the effectiveness of edaravone dexborneol in improving recovery outcomes for patients with acute ischemic stroke.
How similar studies have performed: While this study focuses on a specific real-world application of edaravone dexborneol, similar studies have shown promise in evaluating treatments for acute ischemic stroke.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Beijing
- Junwei Hao — Beijing, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.