Efficacy of Butylphthalide on Symptomatic Atherosclerotic Stenosis in Middle Cerebral Artery (NCT06331494) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Efficacy of Butylphthalide on Symptomatic Atherosclerotic Stenosis in Middle Cerebral Artery
China140 participantsStarted 2024-03-15
Plain-language summary
Ischemic stroke with high incidence, mortality, disability and recurrence rate, has become the leading threat to the health worldwide. Intracranial atherosclerotic stenosis (ICAS) is commonly associated with ischemic stroke, especially in Chinese residents. Patients with severe ICAS are subject to a very high risk of recurrent stroke events, despite best medical therapy available. Unstable or complex atherosclerotic plaques can lead to plaque ruptures and distal embolisms, thereby increasing the risk of ischemic stroke recurrence. Studies have shown that activation of inflammatory states may play a driving role in the formation and development of atherosclerosis. So far, it remains unclear which are the best treatments for this condition, especially for high-risk patients. Dl-3-n-butylphthalide (NBP) is a Class I novel drug independently developed in China and was officially approved for use in acute ischemic stroke. Preclinical data showed that NBP can act multiple effects of anti-inflammation, antioxidation and anti-apoptosis by suppressing pro-inflammatory factors and upregulating the expression of anti-inflammatory factors. It is still undetermined whether combined therapy with NBP could enhance the curative effect of intracranial atherosclerosis. The primary purpose of this trial is to evaluate the efficacy of butylphthalide in reducing the degree of arterial stenosis and stabilizing plaques in patients with severe symptomatic middle cerebral artery stenosis.
Who can participate
Age range55 Years – 75 Years
SexALL
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Inclusion criteria
✓. Female or male aged 55-75 years;
✓. At least one of the following risk factors of atherosclerosis: hypertension, diabetes, hypercholesterolemia, or smoking;
✓. 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;
✓. NIHSS ≤ 20;
✓. mRS ≤ 2 at randomization (pre-morbid historical assessment);
✓. Participants understand the purpose of the study and have signed informed consent form.
Exclusion criteria
✕. Presence of intracranial hemorrhage or other pathological brain diseases;
✕. Plan to or have performed intravenous thrombolysis or mechanical thrombectomy therapy;
What they're measuring
1
Changes in stenosis degree in the responsible artery
Timeframe: 180 days
Trial details
NCT IDNCT06331494
SponsorFirst Affiliated Hospital, Sun Yat-Sen University
✕. Use Butylphthalide during onset between randomization;
✕. Suspect of cardiac embolism, such as atrial fibrillation, artificial heart valves, endocarditis, etc;
✕. Contraindications for the use of clopidogrel or aspirin;
✕. Known allergy history of celery or butylphthalide;
✕. 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;