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

A Real-world Retrospective Study on the Effectiveness and Safety of Butylphthalide in the Treatment of Ischemic Stroke

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Vascular Diseases; Stroke; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Cerebral Infarction; Brain Infarction
• Intervention / Treatment: Other: butylphthalide

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 Type: Observational
• Enrollment (Actual): 81292

Contacts and Locations

Study Locations

• China
  • Shandong Provincial
    • Jinan, Shandong Provincial, China, 250014
      • Shandong Provincial Qianfoshan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Doctors diagnosed with ischemic stroke patients

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Exposed group; A group of patients with ischemic stroke, treated with butylphthalide	Other: butylphthalide; Observational only and no predesigned interventions in this study; Other Names: observational only ,no intervention
Non-exposed group; A group of patients with ischemic stroke, treated with Edaravone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of adverse events	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	90days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NIHSS	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%	90days
mRS	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.	90days

Collaborators and Investigators

• Sponsor: Xin Huang
• Investigators: Study Director: Xin Huang, Qianfoshan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2022
• Primary Completion (Actual): February 1, 2023
• Study Completion (Actual): March 1, 2023

Study Registration Dates

• First Submitted: September 25, 2021
• First Submitted That Met QC Criteria: October 7, 2021
• First Posted (Actual): October 21, 2021

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 6, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Ischemic Strokes; butylphthalide; Real world research
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Cerebrovascular Disorders; Brain Diseases; Infarction; Stroke; Cardiovascular Diseases; Vascular Diseases; Brain Ischemia; Nervous System Diseases; Cerebral Infarction; Brain Infarction; Central Nervous System Diseases; Physiological Effects of Drugs; Platelet Aggregation Inhibitors; Neuroprotective Agents; Protective Agents; 3-n-butylphthalide
• Other Study ID Numbers: QFS-HX-2021-DBT-HGX-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Haven't decided yet

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No