Evaluating the effectiveness and safety of Butylphthalide for ischemic stroke patients
A Real-world Study on the Effectiveness and Safety of Butylphthalide in the Treatment of Ischemic Stroke.
This study is testing if Butylphthalide can safely help people who have had an acute ischemic stroke recover better over about three months.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Qianfoshan Hospital Academic / other |
| Locations | 1 site (Jinan, Shandong Provincial) |
| Trial ID | NCT05068349 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the effectiveness and safety of Butylphthalide in treating patients with acute ischemic stroke. It will enroll 300 eligible participants who will receive intravenous Butylphthalide sodium chloride injections followed by oral capsules over a treatment period of approximately 3 months. The study will also establish a population pharmacokinetic model for elderly patients to understand the drug's blood concentration and its correlation with efficacy and adverse reactions. Data will be collected on various health metrics to evaluate treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have experienced an acute ischemic stroke within the last 48 hours.
Not a fit: Patients with intracranial hemorrhage, severe heart conditions, or significant liver or kidney dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new effective treatment option for patients suffering from ischemic stroke, potentially improving recovery and quality of life.
How similar studies have performed: While there is limited large-scale data on Butylphthalide's efficacy in real-world settings, previous studies have shown promising results in improving neurological outcomes in ischemic stroke patients.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Jinan, Shandong Provincial
- Shandong Provincial Qianfoshan Hospital — Jinan, Shandong Provincial, China (Recruiting)
Study contacts
- Study coordinator: Xueyan Cui
- Email: qfscxy@126.com
- Phone: 15053180972
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.