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Hospital, Fudan University","Shanghai",{"type":48,"coordinates":223},[224,225],121.45806,31.22222,{"lat":225,"lon":224},{"type":59,"investigatorFullName":228,"investigatorTitle":229,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Wei-Hai Xu","MD & PhD",[231,232,234,236,237,239,240,241,242,243,244,245,246,248,249,251],{"name":41,"class":6},{"name":233,"class":6},"Hebei General Hospital",{"name":235,"class":6},"Taihe Hospital",{"name":194,"class":6},{"name":238,"class":6},"Nanjing First Hospital, Nanjing Medical University",{"name":147,"class":6},{"name":167,"class":6},{"name":177,"class":6},{"name":96,"class":6},{"name":212,"class":6},{"name":112,"class":6},{"name":70,"class":6},{"name":247,"class":6},"The First Affiliated Hospital of Zhengzhou University",{"name":186,"class":6},{"name":250,"class":6},"Zhongnan Hospital",{"name":252,"class":6},"Huashan Hospital","100628792","phase-4-pcsk9-inhibitor-for-intracranial-atherosclerosis-related-acute-ischemic-stroke-100628792",false,"NCT07466251","PCSK9 Inhibitor for Intracranial Atherosclerosis Related Acute Ischemic Stroke","PCSK9 Inhibitor for Intracranial Atherosclerosis Related Acute Ischemic Stroke (PISTIAS-3): a Randomized, Double-blind, Placebo-controlled Trial","PISTIAS-3","Inclusion Criteria:\n\n* Age \\>=30 and \\\u003C=80;2.Acute ischemic stroke within 72 hours of onset (as determined by CT\u002FMRI in conjunction with neurological deficit symptoms)\n* Acute ischemic stroke within 72 hours of onset (diagnosed by CT\u002FMRI in conjunction with neurological deficit symptoms)\n* NIHSS score of 4-25 at admission\n* Imaging studies (CTA\u002FDSA\u002FMRA) support intracranial atherosclerosis as the cause of stroke, meeting one of the following criteria: i. The culprit vessel exhibits intracranial atherosclerotic stenosis (ICAS) with a narrowing degree of 50-99%; ii. The culprit vessel exhibits intracranial atherosclerotic occlusion (ICAS-LVO), with successful recanalization achieved via mechanical thrombectomy (immediate expanded thrombolysis in cerebral infarction \\[eTICI\\] grade 2b50-3)\n* Informed consent signed\n\nExclusion Criteria:\n\n* Non-atherosclerotic intracranial arterial stenosis (such as arterial dissection, Moyamoya disease, systemic vasculitis, etc.)\n* Any identifiable source of cardiogenic embolism (such as atrial fibrillation, mechanical valves, left ventricular thrombus, patent foramen ovale, etc.)\n* Imaging findings and clinical presentation suggest that the primary pathophysiology of this event is more consistent with cerebral small vessel disease (e.g., perforator artery occlusion\u002Flacunar infarction)\n* Pre-existing disability prior to this ischemic event (modified Rankin Scale ≥ 2 points)\n* CT or MRI findings suggest extensive cerebral infarction (e.g., ASPECTS score \\\u003C 6 or infarct volume ≥ 70 ml)\n* Has undergone or is scheduled to undergo a vascular stent implantation procedure within the next three months\n* Any intracranial hemorrhage occurring within 3 months prior to enrollment;\n* Intracranial tumors, cerebral aneurysms, or arteriovenous malformations that are assessed as having indications for interventional treatment\n* Severe active bleeding tendency or coagulation disorder\n* Severe dysfunction of vital organs such as the heart, liver, and kidneys\n* Received PCSK9 monoclonal antibody inhibitor therapy within 1 month prior to enrollment or PCSK9 siRNA inhibitor therapy within 6 months prior to enrollment\n* A clear contraindication to statins or a history of intolerance to them\n* Pregnancy, breastfeeding, or planning pregnancy;14.Currently participating in another study","ALL","30 Years","80 Years",{"count":265,"type":266},1212,"ESTIMATED","INTERVENTIONAL",[269],"PHASE4","This study is a prospective, multicenter, double-blind, randomized, placebo-controlled clinical trial designed to evaluate whether early administration of PCSK9 inhibitors can effectively improve functional outcomes at 90 days in patients with ischemic stroke (AIS) associated with intracranial atherosclerotic stenosis (ICAS), primarily assessed using the modified Rankin Scale at 90 days.",[272,273,274],"Acute Ischemic Stroke AIS","Intracranial Atherosclerosis ICAS","Atherosclerotic Plaque",[276,277,278,279,280],"Intracranial Atherosclerosis","intracranial artery stenosis","atherosclerotic plaque","PCSK9 inhibitor","Recaticimab","NOT_YET_RECRUITING","2026-03-11",{"date":284,"type":285},"2026-03-12","ACTUAL",{"date":287,"type":266},"2026-09-01",{"date":289,"type":266},"2029-12-31",{"name":5,"class":6},19]