Comparative Effectiveness of Different Neuroprotectants Among Patients With Acute Ischemic Stroke in Clinical Practice
试验速览
- 阶段
- 不适用
- 发起方
- yongjun wang
- 入组人数
- 20,000
- 试验地点
- 1
- 主要终点
- Effectiveness Outcome Measures
研究概览
简要总结
The primary objective of this study is to compare effectiveness of five different neuroprotectants, including butylphthalide, edaravone, citicoline, cerebrolysin, and piracetam, among patients with acute ischemic stroke.
The secondary objectives of the study are as follows:
- To compare safety of five different neuroprotectents, including butylphthalide, edaravone, citicoline, cerebrolysin, and piracetam, among patients with acute ischemic stroke.
- To compare cost-effectiveness of five different neuroprotectents, including butylphthalide, edaravone, citicoline, cerebrolysin, and piracetam, among patients with acute ischemic stroke.
详细描述
Study Population:The study population will consist of consenting patients who are on neuroprotectant injection for the treatment of acute IS during hospitalization. Hospitals may contribute differing numbers of patients to the total sample size. Primary analyses will be conducted on the total sample size only.
Assessment of Outcomes:The outcome measures in this study include effectiveness, safety and cost measures.
研究设计
- 研究类型
- Observational
- 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
- •At least 18 years old
- •Ischemic stroke confirmed by brain CT or MRI within 14 days of the index event
- •Neuroprotectents administrated during hospitalization
- •Direct admission based on physician evaluation or arrival through the emergency department
- •Ability of patient or legally authorized representative (primarily spouse, parents, adult children, otherwise indicated) to provide informed consent.
排除标准
- 未提供
结局指标
主要结局
Effectiveness Outcome Measures
时间窗: 3 years
* The severity of neurological impairment evaluated by the NIHSS • Disability by mRS * All cause mortality * In-hospital recurrence and recurrence at 3 month post discharge * In-hospital complications * Cognitive disorder evaluated by MMSE * Quality of Life evaluated by EQ5D
次要结局
- Safety Outcome Measures(3 years)
- Cost-effectiveness Outcome Measures(2011.7-2014.6)
研究者
yongjun wang
Beijing Tiantan hospital
Ministry of Science and Technology of the People´s Republic of China