Effectiveness and Safety of Edaravone Dexborneol in Acute Ischemic Stroke: a Multicenter, Prospective, Patient-centered, Real-world Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 4,750
- 试验地点
- 1
- 主要终点
- Proportion of patients with modified Rankin Scale (mRS) score 0-1
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Exposet group
intravenous edaravone dexborneol 37.5mg twice daily
干预措施: edaravone dexborneol (Drug)
结局指标
主要结局
Proportion of patients with modified Rankin Scale (mRS) score 0-1
时间窗: 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
次要结局
- Distribution of mRS score(90±7 days)
- Proportion of patients with mRS 0-2(90±7 days)
- Neurological functional change(at discharge, an average of 7 days)
- Quality of Life (EQ-5D-5L) at 90 days(90±7 days)
研究者
Junwei Hao, MD
Director of Neurology Department
Xuanwu Hospital, Beijing