Clinical trial NCT05068349: For Patients With Ischemic Stroke, Clinically Study the Effectiveness and Safety of Butylphthalide.
Official title: A Real-world Study on the Effectiveness and Safety of Butylphthalide in the Treatment of Ischemic Stroke.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Stroke
Cerebral Infarction
Brain Infarction
Brain Ischemia
Nervous System Diseases
Central Nervous System Diseases
Vascular Diseases
Keywords: Butylphthalide
Ischemic Strokes
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2021-10-05
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A single-group clinical trial is a study with only one group, and no corresponding control group is designed for the experimental group.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The incidence of adverse events caused by treatment
timeFrame: 90 days
Secondary outcomes:
measure: NIHSS
timeFrame: 90 days
measure: mRS
timeFrame: 90 days
measure: Correlation between blood drug concentration and adverse events
timeFrame: 90 days
Other outcomes:
measure: hemoglobin concentration
timeFrame: 90days
measure: ECG
timeFrame: 90days
measure: White blood cell count
timeFrame: 90days
Locations:
city: Jinan
country: China
facility: Shandong Provincial Qianfoshan Hospital
state: Shandong Provincial
Study officials:
affiliation: Qianfoshan Hospital
name: Xin Huang
role: STUDY_DIRECTOR
References: