Clinical trial NCT05644223: Effectiveness and Safety of Edaravone Dexborneol in Acute Ischemic Stroke
Official title: Effectiveness and Safety of Edaravone Dexborneol in Acute Ischemic Stroke: a Multicenter, Prospective, Patient-centered, Real-world Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Ischemic Stroke
Keywords: acute ischemic stroke
edaravone dextrol
real-world study
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2022-12-09
Enrollment: 4750
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who aged more than 18 years old and diagnosed as acute ischemic stroke (time from symptom onset to admission ≤ 14 days) with pre-stroke mRS ≤1 can be enrolled in this 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.

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.

Primary outcomes:
measure: Proportion of patients with modified Rankin Scale (mRS) score 0-1
timeFrame: 90±7 days
Secondary outcomes:
measure: Proportion of patients with mRS 0-2
timeFrame: 90±7 days
measure: Distribution of mRS score
timeFrame: 90±7 days
measure: Neurological functional change
timeFrame: at discharge, an average of 7 days
measure: Quality of Life (EQ-5D-5L) at 90 days
timeFrame: 90±7 days
Other outcomes:
measure: Symptomatic intracranial hemorrhage (sICH)
timeFrame: during hospitalization, an average of 7 days
measure: Intracranial hemorrhage during hospitalization (ICH)
timeFrame: during hospitalization
measure: All-cause death
timeFrame: 90±7 days
measure: Adverse events
timeFrame: during the use of edaravone dexborneol
Locations:
city: Beijing
country: China
facility: Junwei Hao
Study officials:
References: