Comparative Effectiveness of Neuroprotectants on Acute Ischemic Stroke
CER
Comparative Effectiveness of Different Neuroprotectants Among Patients With Acute Ischemic Stroke in Clinical Practice
1 other identifier
observational
20,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2011
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 13, 2012
CompletedFirst Posted
Study publicly available on registry
March 16, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedMarch 16, 2012
March 1, 2012
2.3 years
March 13, 2012
March 15, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Safety Outcome Measures
3 years
Cost-effectiveness Outcome Measures
2011.7-2014.6
Eligibility Criteria
The study population will consist of consenting patients who are on neuroprotectant injection for the treatment of acute IS during hospitalization.
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- yongjun wanglead
Study Sites (1)
Tiantan hospital
Beijing, Beijing Municipality, 100050, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Beijing Tiantan hospital
Study Record Dates
First Submitted
March 13, 2012
First Posted
March 16, 2012
Study Start
July 1, 2011
Primary Completion
November 1, 2013
Study Completion
June 1, 2014
Last Updated
March 16, 2012
Record last verified: 2012-03