Clinical trial
Effectiveness and Safety of Edaravone Dexborneol in Acute Ischemic Stroke: a Multicenter, Prospective, Patient-centered, Real-world Cohort Study
Name
SMA-AIS-008
Description
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.
Trial arms
Trial start
2023-01-01
Estimated PCD
2024-06-30
Trial end
2024-06-30
Status
Recruiting
Treatment
edaravone dexborneol
intravenous edaravone dexborneol 37.5mg twice daily
Arms:
Exposet group
Size
4750
Primary endpoint
Proportion of patients with modified Rankin Scale (mRS) score 0-1
90±7 days
Eligibility 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.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': True, 'targetDuration': '90 Days', 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 4750, 'type': 'ESTIMATED'}}
Updated at
2023-08-31
1 organization
1 product
1 indication
Organization
Xuanwu HospitalProduct
EdaravoneIndication
Stroke