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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Vascular Diseases; Stroke; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Cerebral Infarction; Brain Infarction
• Intervention / Treatment: Drug: Butylphthalide

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 Type: Interventional
• Enrollment (Estimated): 300
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Xueyan Cui; Phone Number: 15053180972; Email: qfscxy@126.com
• Study Contact Backup: Name: Shuxian Lv; Phone Number: 15154126233

Study Locations

• China
  • Shandong Provincial
    • Jinan, Shandong Provincial, China
      • Recruiting
      • Shandong Provincial Qianfoshan Hospital
      • Contact: Xin Huang; Email: 13791120711@126.com
      • Contact: Xueyan Cui; Email: qfscxy@126.com
      • Principal Investigator: Shuxian Lv

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Correlation between blood drug concentration and adverse events	Try to find the relationship between pharmacokinetic parameters and adverse events	90 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
hemoglobin concentration	The normal range of hemoglobin concentration is 120-160g/L for adult males and 110-150g/L for adult females	90days
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
White blood cell count	White blood cell normal value parameters: adult white blood cell normal value (4.0~10.0)*109 /L	90days

Collaborators and Investigators

• Sponsor: Qianfoshan Hospital
• Investigators: Study Director: Xin Huang, Qianfoshan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2022
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: September 20, 2021
• First Submitted That Met QC Criteria: October 2, 2021
• First Posted (Actual): October 5, 2021

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 6, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Butylphthalide; Ischemic Strokes
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Cardiovascular Diseases; Cerebrovascular Disorders; Brain Diseases; Infarction; Stroke; Vascular Diseases; Ischemic Stroke; Brain Ischemia; Nervous System Diseases; Cerebral Infarction; Brain Infarction; Central Nervous System Diseases; Physiological Effects of Drugs; Platelet Aggregation Inhibitors; Neuroprotective Agents; Protective Agents; 3-n-butylphthalide
• Other Study ID Numbers: QFS-HX-2021-DBT-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No