Comparative Effectiveness of Neuroprotectants on Acute Ischemic Stroke

Acute Ischemic Stroke Clinical Trial

— CER  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01556854
• Other study ID #: 2011BAI08B02-01
• Status: Recruiting
• Phase: N/A
• First received: March 13, 2012
• Last updated: March 15, 2012
• Start date: July 2011
• Est. completion date: June 2014

Study information

• Verified date: March 2012
• Source: Ministry of Science and Technology of the People´s Republic of China
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Science and TechnologyChina: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20000
• Est. completion date: June 2014
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Ischemia
• Stroke

Locations

Country	Name	City	State
China	Tiantan hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
yongjun wang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes
Secondary	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	No