Clinical Comprehensive Evaluation of Neuroprotective Drugs for Acute Ischemic Stroke
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 600
- 主要终点
- Proportion of patients with Modified Rankin Scale（mRS ）scores of 0-1
研究概览
简要总结
This study conducted a comprehensive evaluation of commonly used neuroprotective agents in acute ischemic stroke, assessing their real-world value across six dimensions: safety, efficacy, cost-effectiveness, innovativeness, appropriateness, and accessibility. Employing a prospective observational design, it primarily investigates the association of edaravone and dexrazoxane with clinical outcomes in patients with mild-to-moderate stroke, with subgroup analyses performed according to Trial of Org 10172 in Acute Stroke Treatment （TOAST ）classification.
详细描述
A comprehensive evaluation of commonly used clinical neuroprotective drugs was conducted, analyzing their practical application value in acute ischemic stroke treatment across six dimensions: safety, efficacy, cost-effectiveness, innovation, appropriateness, and accessibility. In a real-world clinical setting, this prospective observational study design primarily evaluates the association between edaravone and dexrazoxane usage and the efficacy and safety outcomes in patients with mild-to-moderate ischemic stroke, while conducting subgroup analyses based on different Trial of Org 10172 in Acute Stroke Treatment （TOAST ）classifications.
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
- •1: Age≥18
- •2: Acute ischemic stroke in the anterior circulation occurring within 48 hours
- •3: Baseline NIHSS score of 1-15 points (mild stroke: baseline NIHSS score of 1-5 points; moderate stroke: baseline NIHSS score of 6-15 points)
- •4: Pre-onset mRS score≤1
- •5: Use of Edaravone (injection or tablets)
- •6: Exclude intracranial hemorrhage
- •7: Sign the informed consent form
排除标准
- •1: A head CT or MRI scan indicates the presence of intracranial hemorrhagic disease
- •2: Patients with cerebral embolism or suspected cerebral embolism who also have severe atrioventricular block, atrial fibrillation, myocardial infarction, valvular heart disease, infective endocarditis, or a heart rate below 50 beats per minute
- •3: Abnormal liver function (ALT or AST transaminase levels exceeding the upper limit of normal), abnormal kidney function (creatinine levels exceeding the upper limit of normal), or individuals with other severe systemic diseases, etc
- •4: Allergy to the test drug
结局指标
主要结局
Proportion of patients with Modified Rankin Scale（mRS ）scores of 0-1
时间窗: 90 days
次要结局
- Percentage reduction in National Institutes of Health Stroke Scale （NIHSS ）score compared to pre-treatment(90 days after medication)
- Proportion of patients with mRS scores of 0-2(30 days)
研究者
LI YAN
Chief Pharmacist
Qianfoshan Hospital