Comparative Effectiveness of Neuroprotectants on Acute Ischemic Stroke

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01556854

Acronym

CER

Enrollment

20000

Registered

2012-03-16

Start date

2011-07-31

Completion date

2014-06-30

Last updated

2012-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Ischemic Stroke

Keywords

ginkgo leaves, butylphthalide, edaravone, citicoline, cerebrolysin, piracetam, Neuroprotectants

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.

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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
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.

Countries

China

Outcome results