Comparative Effectiveness of Neuroprotectants on Acute Ischemic Stroke (CER)
Recruitment status was: Recruiting
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.
Acute Ischemic Stroke
|Study Design:||Time Perspective: Prospective|
|Official Title:||Comparative Effectiveness of Different Neuroprotectants Among Patients With Acute Ischemic Stroke in Clinical Practice|
- Effectiveness Outcome Measures [ Time Frame: 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
- Safety Outcome Measures [ Time Frame: 3 years ]
- 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 [ Time Frame: 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
|Study Start Date:||July 2011|
|Estimated Study Completion Date:||June 2014|
|Estimated Primary Completion Date:||November 2013 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01556854
|Beijing, Beijing, China, 100050|