protocolSection identificationModule nctId: NCT06331494, orgStudyIdInfo id: SICAS, briefTitle: Efficacy of Butylphthalide on Symptomatic Atherosclerotic Stenosis in Middle Cerebral Artery, acronym: SICAS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2026-05-31, completionDateStruct date: 2026-08-31, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: First Affiliated Hospital, Sun Yat-Sen University, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Ischemic Stroke, Acute, conditions: Intracranial Atherosclerosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 140, type: ESTIMATED, armsInterventionsModule interventions name: Butylphthalide, interventions name: Placebo, outcomesModule primaryOutcomes measure: Changes in stenosis degree in the responsible artery, secondaryOutcomes measure: Stroke recurrence, secondaryOutcomes measure: Change in plaque volumes the responsible artery, secondaryOutcomes measure: Changes in hemorrhage and enhancement volumes of atherosclerotic plaque in the responsible artery, secondaryOutcomes measure: Changes in National Institutes of Health Stroke Scale (NIHSS), secondaryOutcomes measure: Proportion of patients with modified Rankin Scale score (mRS) 0-2, secondaryOutcomes measure: Change in the value of cerebral blood flow (CBF) in the responsible artery territory, secondaryOutcomes measure: Change in concentrations of serum lipid profiles, eligibilityModule sex: ALL, minimumAge: 55 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The First Affiliated Hospital, Sun Yat-sen University, city: Guangzhou, state: Guangdong, zip: 510080, country: China, contacts name: Jinsheng Zeng, role: CONTACT, phone: +8613322800657, email: zengjs@pub.guangzhou.gd.cn, contacts name: Shihui Xing, role: CONTACT, phone: +8613602755395, email: xingshih@mail.sysu.edu.cn, geoPoint lat: 23.11667, lon: 113.25, hasResults: False