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

Completed

• Conditions: Cerebral Infarction; Central Nervous System Diseases; Stroke; Brain Ischemia; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Infarction
• Interventions: Other: butylphthalide

• Registration Number: NCT05086874
• Lead Sponsor: Xin Huang

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2021-09-25
• Study First Submitted QC: 2021-10-07
• Study First Posted: 2021-10-21
• Study Start: 2022-05-07
• Primary Completion: 2023-02-01
• Study Completion: 2023-03-01
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-06
• Last Update Posted: 2024-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81292

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Exposed group	butylphthalide	A group of patients with ischemic stroke, treated with butylphthalide

Primary Outcome Measures

Name	Time	Method
The incidence of adverse events	90days	The probability of unanticipated and adverse medical events after the patient receives medication, but it does not necessarily have a causal relationship with the treatment

Secondary Outcome Measures

Name	Time	Method
mRS	90days	Modified Rankin scale (mRS) is an indicator of the efficacy of functional disability. The score ranges from 0 to 5 points, and the clinical score will be increased to 6 points to indicate death. The higher the score, the more disability the patient is.
NIHSS	90days	NIH stroke scale (NIHSS) to assess the degree of neurological deficit in stroke patients. The score ranges from 0 to 42 points, the higher the score, the more severe the nerve damage. Patients with a baseline assessment of\> 16 points are likely to die, while those with a score of \<6 are likely to recover well; for each additional point, the probability of a good prognosis is reduced by 17%

Trial Locations

Locations (1)

Shandong Provincial Qianfoshan Hospital; 🇨🇳 Jinan, Shandong Provincial, China