Comparative Effectiveness of Neuroprotectants on Acute Ischemic Stroke

• Conditions: Acute Ischemic Stroke

• Registration Number: NCT01556854
• Lead Sponsor: yongjun wang

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 Timeline

• Study Start: 2011-07
• Status Verified: 2012-03
• Study First Submitted: 2012-03-13
• Study First Submitted QC: 2012-03-15
• Last Update Submitted: 2012-03-15
• Study First Posted: 2012-03-16
• Last Update Posted: 2012-03-16
• Primary Completion: 2013-11
• Study Completion: 2014-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Effectiveness Outcome Measures	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 Outcome Measures

Name	Time	Method
Safety Outcome Measures	3 years	* 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.
Cost-effectiveness Outcome Measures	2011.7-2014.6	* 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

Trial Locations

Locations (1)

Tiantan hospital; 🇨🇳 Beijing, Beijing, China