For Patients With Ischemic Stroke, Clinically Study the Effectiveness and Safety of Butylphthalide.

NCT05068349 | Recruiting Phase 4 DMC

• 1 other identifier: QFS-HX-2021-DBT-001
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, open, single-arm, the real world of clinical trials. The researchers plan to recruit 300 eligible patients. The main purpose of this study is to evaluate the effectiveness and safety of butylphthalide in the treatment of ischemic stroke, and to establish a population pharmacokinetic model of butylphthalide in elderly patients to explore its blood drug concentration. Correlation with its efficacy and adverse reactions.

Conditions

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

Keywords

Butylphthalide; Ischemic Strokes

Outcome Measures

Primary Outcomes (1)

• The incidence of adverse events caused by treatment

  In a clinical trial, the probability of an unexpected and adverse medical event that occurs after a patient or clinical subject receives a trial drug, but it does not necessarily have a causal relationship with the treatment.

  90 days

Secondary Outcomes (3)

• NIHSS

  90 days

• mRS

  90 days

• Correlation between blood drug concentration and adverse events

  90 days

Other Outcomes (3)

• hemoglobin concentration

  90days

• ECG

  90days

• White blood cell count

  90days

Study Arms (1)

A group of patients with ischemic stroke were treated with butylphthalide injection and capsules

EXPERIMENTAL

Patients eligible for inclusion and exclusion are only divided into one group, no controls or other.

Drug: Butylphthalide

Interventions

Butylphthalide DRUG

Butylphthalide sodium chloride injection 25mg, 2 times a day, 7-14 days, followed by 0.2g butylphthalide soft capsules, 3 times a day, 76-83 days, a total of 90 days.

Also known as: 3-n-Butylphthalide

A group of patients with ischemic stroke were treated with butylphthalide injection and capsules

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Female or male aged ≥ 18 years.
• \. Acute ischemic stroke within 48 hours of onset
• \. Examination to exclude intracranial hemorrhage
• \. Provision of informed consent.

You may not qualify if:

• Head CT or MRI suggests the presence of intracranial hemorrhagic disease
• Patients with cerebral embolism or suspected cerebral embolism with severe atrioventricular block disease, atrial fibrillation, myocardial infarction, heart valve disease, infective endocarditis, heart rate less than 50 beats per minute
• Abnormal liver function (transaminase ALT or AST exceeding the upper limit of normal), abnormal renal function (creatinine exceeding the upper limit of normal), or suffering from other serious systemic diseases, etc
• Allergy to Butylphthalide

Sponsors & Collaborators

• Qianfoshan Hospital: lead

Study Sites (1)

Shandong Provincial Qianfoshan Hospital

Jinan, Shandong Provincial, China

RECRUITING

MeSH Terms

Conditions

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

Interventions

3-n-butylphthalide

Condition Hierarchy (Ancestors)

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

Study Officials

• Xin Huang

  Qianfoshan Hospital

  STUDY DIRECTOR

Central Study Contacts

Xueyan Cui

CONTACT

15053180972; qfscxy@126.com

Shuxian Lv

CONTACT

15154126233

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Masking Details: Intervention measures are closer to the real-world clinical environment to make up for the shortcomings of RCT.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Pharmacist

Model Details: A single-group clinical trial is a study with only one group, and no corresponding control group is designed for the experimental group.

Study Record Dates

• First Submitted: September 20, 2021
• First Posted: October 5, 2021
• Study Start: May 7, 2022
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 9, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

CN (1)