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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05068349
• Other study ID #: QFS-HX-2021-DBT-001
• Status: Recruiting
• Phase: Phase 4
• Start date: May 7, 2022
• Est. completion date: December 2025

Study information

• Verified date: April 2024
• Source: Qianfoshan Hospital
• Contact: Xueyan Cui
• Phone: 15053180972
• Email: qfscxy[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
China	Shandong Provincial Qianfoshan Hospital	Jinan	Shandong Provincial

Sponsors (1)

Lead Sponsor	Collaborator
Qianfoshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	hemoglobin concentration	The normal range of hemoglobin concentration is 120-160g/L for adult males and 110-150g/L for adult females	90days
Other	ECG	The electrocardiogram (ECG) mainly checks whether the patient's heart rate, PR interval, QRS interval, and QT interval are within the normal range.	90days
Other	White blood cell count	White blood cell normal value parameters: adult white blood cell normal value (4.0~10.0)*109 /L	90days
Primary	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	NIHSS	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%	90 days
Secondary	mRS	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.	90 days
Secondary	Correlation between blood drug concentration and adverse events	Try to find the relationship between pharmacokinetic parameters and adverse events	90 days