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

NCT ID: NCT05068349

Last Updated: 2024-04-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-07
• Study Completion Date: 2025-12-31

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.

Detailed Description

Ischemic stroke is one of the diseases that seriously threaten human health, with the characteristics of high incidence, high disability and high recurrence rate. Patients will not only suffer from impaired physical function, but also mental symptoms, social function and other obstacles, which seriously affect the quality of life.

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 the treatment of ischemic stroke with butylphthalide, there is still a lack of big data research based on real-world efficacy and safety; there is a lack of data on the pharmacokinetics of elderly patients and their correlation with adverse reactions.

Thus, it is estimated that 300 patients will be enrolled and given intravenous butylphthalide sodium chloride injection 25mg twice a day for 7-14 days, and then oral butylphthalide soft capsule 0.2g three times a day for 76-83 days. The patients will be collected for experiment before and after treatment. Laboratory data, electrocardiogram, NIHSS, mRS, combined medication and adverse events, etc., to evaluate the effectiveness and safety of butylphthalide in the treatment of ischemic stroke. In addition, a population pharmacokinetic model of butylphthalide in elderly patients was established for 50 of them.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

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

Group Type: EXPERIMENTAL

Butylphthalide

Intervention Type: 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.

Interventions

Butylphthalide

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.

Intervention Type: DRUG

Other Intervention Names

3-n-Butylphthalide

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 1.Head CT or MRI suggests the presence of intracranial hemorrhagic disease
• 2.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
• 3.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
• 4.Allergy to Butylphthalide

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Qianfoshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Xin Huang

Chief Pharmacist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xin Huang

Role: STUDY_DIRECTOR

Qianfoshan Hospital

Locations

Shandong Provincial Qianfoshan Hospital

Jinan, Shandong Provincial, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xueyan Cui

Role: CONTACT

qfscxy@126.com

15053180972

Shuxian Lv

Role: CONTACT

15154126233

Facility Contacts

Xin Huang

Role: primary

13791120711@126.com

Xueyan Cui

Role: backup

qfscxy@126.com

Other Identifiers

QFS-HX-2021-DBT-001

Identifier Type: -

Identifier Source: org_study_id