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

NCT ID: NCT05086874

Last Updated: 2024-04-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

81292 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-07

Study Completion Date

2023-03-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Stroke Cerebral Infarction Brain Infarction Brain Ischemia Nervous System Diseases Central Nervous System Diseases Vascular Diseases Cardiovascular Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Exposed group

A group of patients with ischemic stroke, treated with butylphthalide

butylphthalide

Intervention Type OTHER

Observational only and no predesigned interventions in this study

Non-exposed group

A group of patients with ischemic stroke, treated with Edaravone

No interventions assigned to this group

Interventions

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butylphthalide

Observational only and no predesigned interventions in this study

Intervention Type OTHER

Other Intervention Names

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observational only ,no intervention

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xin Huang

OTHER

Sponsor Role lead

Responsible Party

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Xin Huang

Chief Pharmacist

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Xin Huang

Role: STUDY_DIRECTOR

Qianfoshan Hospital

Locations

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Shandong Provincial Qianfoshan Hospital

Jinan, Shandong Provincial, China

Site Status

Countries

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China

Other Identifiers

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QFS-HX-2021-DBT-HGX-001

Identifier Type: -

Identifier Source: org_study_id

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