Comparative Effectiveness of Neuroprotectants on Acute Ischemic Stroke

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparative Effectiveness of Different Neuroprotectants Among Patients With Acute Ischemic Stroke in Clinical Practice

Conditions
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Acute Ischemic Stroke

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness Outcome Measures | 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 | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Outcome Measures | death prolonged inpatient hospitalization a life-threatening experience (that is, immediate risk of dying) persistent or significant disability/incapacity or is considered significant by the physician for any other reason. | 3 years | 
| Cost-effectiveness Outcome Measures | Medical cost at discharge Drug cost at discharge Neuroprotectents cost at discharge Administration cost at discharge Medical cost at 3 month post discharge Drug cost at 3 month post discharge | 2011.7-2014.6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ginkgo leaves, butylphthalide, edaravone, citicoline, cerebrolysin, piracetam, Neuroprotectants