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.
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;
Presence of intracranial hemorrhage or other pathological brain diseases;
Plan to or have performed intravenous thrombolysis or mechanical thrombectomy therapy;
Unable to undergo MRI examination;
Use Butylphthalide during onset between randomization;
Parallel
Butylphthalide
DrugButylphthalide Sodium Chloride injection for 10±3 days, oral Butylphthalide soft capsules for day 11±3 to day 180.
Placebo
DrugButylphthalide Placebo injection for 10±3 days, oral Butylphthalide Placebo soft capsules for day 11±3 to day 180.
Changes in stenosis degree in the responsible artery
Intracranial atherosclerosis is evaluated by high-resolution MRI vessel-wall imaging technique.
Stroke recurrence
Rate of new-onset ischemic stroke or TIA in the territory of the symptomatic middle cerebral artery within 180 days.
Change in plaque volumes the responsible artery
Change in plaque volumes in the symptomatic middle cerebral artery at 90 days and 180 days.
Changes in hemorrhage and enhancement volumes of atherosclerotic plaque in the responsible artery
Changes in hemorrhage and enhancement volumes of atherosclerotic plaque in the symptomatic middle cerebral artery at 90 days and 180 days.
Changes in National Institutes of Health Stroke Scale (NIHSS)
National Institutes of Health Stroke Scale (NIHSS, range: 0 - 42) at baseline and discharge.
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