PCSK9 Inhibitor for Intracranial Atherosclerosis Related Acute Ischemic Stroke (NCT07466251) | Clinical Trial Compass
Not Yet RecruitingPhase 4
PCSK9 Inhibitor for Intracranial Atherosclerosis Related Acute Ischemic Stroke
China1,212 participantsStarted 2026-09-01
Plain-language summary
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.
Who can participate
Age range30 Years – 80 Years
SexALL
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Inclusion Criteria:
* Age \>=30 and \<=80;2.Acute ischemic stroke within 72 hours of onset (as determined by CT/MRI in conjunction with neurological deficit symptoms)
* Acute ischemic stroke within 72 hours of onset (diagnosed by CT/MRI in conjunction with neurological deficit symptoms)
* NIHSS score of 4-25 at admission
* Imaging studies (CTA/DSA/MRA) 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)
* Informed consent signed
Exclusion Criteria:
* Non-atherosclerotic intracranial arterial stenosis (such as arterial dissection, Moyamoya disease, systemic vasculitis, etc.)
* Any identifiable source of cardiogenic embolism (such as atrial fibrillation, mechanical valves, left ventricular thrombus, patent foramen ovale, etc.)
* 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/lacunar infarction)
* Pre-existing disability prior to this ischemic event (modified Rankin Scale ≥ 2 points)
* CT or MRI findings suggest extensive cerebral infarction (e.g., ASPECTS…