Comparative Effectiveness of Different Neuroprotectants Among Patients With Acute Ischemic Stroke in Clinical Practice
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- yongjun wang
- Enrollment
- 20,000
- Locations
- 1
- Primary Endpoint
- Effectiveness Outcome Measures
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Observational
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Effectiveness Outcome Measures
Time Frame: 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
Secondary Outcomes
- Safety Outcome Measures(3 years)
- Cost-effectiveness Outcome Measures(2011.7-2014.6)
Investigators
yongjun wang
Beijing Tiantan hospital
Ministry of Science and Technology of the People´s Republic of China