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

Qianfoshan Hospital

Status and phase: Enrolling; Phase 4

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

Treatments: Drug: Butylphthalide

Study type: Interventional

Funder types: Other

Identifiers

NCT05068349

QFS-HX-2021-DBT-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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300 participants in 1 patient group

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

Experimental group

Description:

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

Treatment:

Drug: Butylphthalide