Comparative Effectiveness of Neuroprotectants on Acute Ischemic Stroke (CER)

yongjun wang

Status: Unknown

Conditions: Acute Ischemic Stroke

Study type: Observational

Funder types: Other

Identifiers

NCT01556854

2011BAI08B02-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.