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

NCT05086874 | Completed DMC

• 1 other identifier: QFS-HX-2021-DBT-HGX-001
• Study Type: observational
• Target: 81,292
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

butylphthalide; Ischemic Strokes; Real world research

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• NIHSS

  90days

• mRS

  90days

Study Arms (2)

Exposed group

A group of patients with ischemic stroke, treated with butylphthalide

Other: butylphthalide

Non-exposed group

A group of patients with ischemic stroke, treated with Edaravone

Interventions

butylphthalide OTHER

Observational only and no predesigned interventions in this study

Also known as: observational only ,no intervention

Exposed group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Doctors diagnosed with ischemic stroke patients

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Xin Huang: lead

Study Sites (1)

Shandong Provincial Qianfoshan Hospital

Jinan, Shandong Provincial, 250014, China

Location

MeSH Terms

Conditions

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

Interventions

3-n-butylphthalide

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Xin Huang

  Qianfoshan Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Pharmacist

Study Record Dates

• First Submitted: September 25, 2021
• First Posted: October 21, 2021
• Study Start: May 7, 2022
• Primary Completion: February 1, 2023
• Study Completion: March 1, 2023
• Last Updated: April 9, 2024

Record last verified: 2024-04

Locations

CN (1)