Using Real-world Evidence to Analyze the Clinical Effects and Adverse Events of Butylphthalide in Stroke Patients

Xin Huang

Status: Completed

Conditions: Brain Ischemia; Cerebral Infarction; Stroke; Brain Infarction; Central Nervous System Diseases; Cardiovascular Diseases; Nervous System Diseases; Vascular Diseases

Treatments: Other: butylphthalide

Study type: Observational

Funder types: Other

Identifiers

NCT05086874

QFS-HX-2021-DBT-HGX-001

Details and patient eligibility

About

This is a retrospective, multi-center, real-world study. The researchers plan to include 10,000 cases of ischemic stroke patients using butylphthalide and 10,000 cases of ischemic stroke patients using Edaravone. The main purpose is to analyze the effectiveness and safety of butylphthalide and establish the drug risk assessment management plan.

Full description

Ischemic stroke is a type of syndrome in which blood supply to the brain is impaired due to various reasons, leading to local brain tissue ischemia, hypoxic necrosis, and corresponding neurological deficits. It has a high incidence, high morbidity and disability. Features of high recurrence rate.

Butylphthalide can improve the damage of central nervous system in patients with acute ischemic stroke, and can promote the improvement of patients with neurological deficits. Regarding butylphthalide in the treatment of ischemic stroke, there is still a lack of big data research based on the efficacy and safety of the real world.

Therefore, it is planned to include 10,000 patients who used butylphthalide or Edaravone in five hospitals from 2019 to 2021, and record the basic information of the patients, medication status and related test results. The data was cleaned, sorted and analyzed to evaluate the effectiveness and safety of butylphthalide in the treatment of ischemic stroke.

Enrollment: 81,292 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• From January 2019 to August 2021, clinicians diagnosed patients with ischemic stroke requiring hospitalization.

Exclusion criteria

• Patients who are unable to obtain information such as medical advice, laboratory test results, etc.

Trial design

81,292 participants in 2 patient groups

Exposed group

Description:

A group of patients with ischemic stroke, treated with butylphthalide

Treatment:

Other: butylphthalide

Non-exposed group

Description:

A group of patients with ischemic stroke, treated with Edaravone