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

Sponsor

Qianfoshan Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05068349

Collaborator

(none)

300

Enrollment

Location

Arm

42.8

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke Cerebral Infarction Brain Infarction Brain Ischemia Nervous System Diseases Central Nervous System Diseases Vascular Diseases	Drug: Butylphthalide	Phase 4

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

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

Masking:

None (Open Label)

Masking Description:

Intervention measures are closer to the real-world clinical environment to make up for the shortcomings of RCT.

Primary Purpose:

Treatment

Official Title:

A Real-world Study on the Effectiveness and Safety of Butylphthalide in the Treatment of Ischemic Stroke.

Actual Study Start Date :

May 7, 2022

Anticipated Primary Completion Date :

Sep 1, 2025

Anticipated Study Completion Date :

Dec 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: 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. Other Names: 3-n-Butylphthalide

Arm

Intervention/Treatment

Experimental: 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.

Drug: 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.

Other Names:

3-n-Butylphthalide

Outcome Measures

Primary Outcome Measures

The incidence of adverse events caused by treatment [90 days]
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.

Secondary Outcome Measures

NIHSS [90 days]
NIH stroke scale (NIHSS) to assess the degree of neurological deficit in stroke patients. The score ranges from 0 to 42 points, the higher the score, the more severe the nerve damage. Patients with a baseline assessment of> 16 points are likely to die, while those with a score of <6 are likely to recover well; for each additional point, the probability of a good prognosis is reduced by 17%
mRS [90 days]
Modified Rankin scale (mRS) is an indicator of the efficacy of functional disability. The score ranges from 0 to 5 points, and the clinical score will be increased to 6 points to indicate death. The higher the score, the more disability the patient is.
Correlation between blood drug concentration and adverse events [90 days]
Try to find the relationship between pharmacokinetic parameters and adverse events

Other Outcome Measures

hemoglobin concentration [90days]
The normal range of hemoglobin concentration is 120-160g/L for adult males and 110-150g/L for adult females
ECG [90days]
The electrocardiogram (ECG) mainly checks whether the patient's heart rate, PR interval, QRS interval, and QT interval are within the normal range.
White blood cell count [90days]
White blood cell normal value parameters: adult white blood cell normal value (4.0~10.0)*109 /L

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

1. Female or male aged ≥ 18 years.
1. Acute ischemic stroke within 48 hours of onset
1. Examination to exclude intracranial hemorrhage
1. 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