Efficacy of Butylphthalide on Symptomatic Atherosclerotic Stenosis in Middle Cerebral Artery

Launched by FIRST AFFILIATED HOSPITAL, SUN YAT-SEN UNIVERSITY · Mar 19, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called butylphthalide on patients with severe narrowing of the middle cerebral artery, which can lead to strokes. The main goal is to see if butylphthalide can help reduce the narrowing of the arteries and stabilize any unstable plaque that might cause a stroke. This is particularly important for patients who have already experienced strokes or transient ischemic attacks (TIAs), as they are at a high risk of having another stroke.

To participate in the trial, individuals must be between the ages of 55 and 75 and have at least one risk factor for atherosclerosis, such as high blood pressure, diabetes, high cholesterol, or smoking. They should also have been diagnosed with significant narrowing of the middle cerebral artery and have experienced a stroke or TIA within the past week. Participants will undergo regular assessments to determine the effects of the treatment. It's important to note that certain medical conditions and treatments may exclude someone from joining the trial, so potential participants should discuss their health history with their doctor to see if they qualify.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Female or male aged 55-75 years;
• • 2. At least one of the following risk factors of atherosclerosis: hypertension, diabetes, hypercholesterolemia, or smoking;
• • 3. Symptomatic atherosclerotic stenosis in middle cerebral artery: large artery atherosclerotic cerebral infarction or TIA within 7 days of onset; 70%-99% stenosis of the responsible middle cerebral artery \[M1\] confirmed by high-resolution MRI examination (referred to Warfarin-Aspirin Symptomatic Intracranial Disease standard); new-onset infarction confirmed by diffusion weighted imaging (DWI) or TIA symptoms in the territory of the responsible artery supply;
• • 4. NIHSS ≤ 20;
• • 5. mRS ≤ 2 at randomization (pre-morbid historical assessment);
• • 6. Participants understand the purpose of the study and have signed informed consent form.
• Exclusion Criteria:
• • 1. Presence of intracranial hemorrhage or other pathological brain diseases;
• • 2. Plan to or have performed intravenous thrombolysis or mechanical thrombectomy therapy;
• • 3. Unable to undergo MRI examination;
• • 4. Use Butylphthalide during onset between randomization;
• • 5. Suspect of cardiac embolism, such as atrial fibrillation, artificial heart valves, endocarditis, etc;
• • 6. Contraindications for the use of clopidogrel or aspirin;
• • 7. Known allergy history of celery or butylphthalide;
• • 8. Severe liver dysfunction (aspartate aminotransferase or alanine transaminase \> 2 times normal upper limit) or severe renal dysfunction (creatinine value \> 1.5 times normal upper limit), heart failure, asthma, etc;
• • 9. History of intracranial hemorrhage, coagulation disorders, systemic bleeding, thrombocytopenia, or other hematological disorders;
• • 10. Plan to perform other surgical procedures or interventional treatments that may require termination of investigational drug use;
• • 11. Severe non-cerebrovascular diseases with an expected survival time less than 3 months;
• • 12. Actively participating in another drug or device trial;
• • 13. Use any drugs with the same or similar mechanism as Butylphthalide during the follow-up period;
• • 14. Unsuitable for this trial from the opinion of the investigators.