PCSK9 Inhibitor With Statin Therapy for Asymptomatic Intracranial Atherosclerosis
Trial Parameters
Eligibility Fast-Check
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Brief Summary
This is a prospective, multicenter, open-label, blinded-endpoint, randomized controlled trial designed to evaluate the efficacy and safety of PCSK9 inhibitor combined with statin therapy compared to statin monotherapy in reversing asymptomatic intracranial atherosclerosis, assessed using high-resolution magnetic resonance imaging of the intracranial vessel walls.
Eligibility Criteria
Inclusion Criteria: 1. Age ≥18 and ≤60, male or female; 2. Asymptomatic intracranial artery stenosis (50%-99%) in the internal carotid artery (C6-7 segments), middle cerebral artery (M1 segment), vertebral artery (V4 segment), or basilar artery, confirmed by angiography (MRA, CTA, or DSA); 3. Atherosclerosis identified as the cause of intracranial artery stenosis by high-resolution magnetic resonance imaging; 4. No previous ischemic cerebrovascular events (including ischemic stroke or transient ischemic attack). 5. Baseline low-density lipoprotein cholesterol ≥ 2.6 mmol/L; 6. Informed consent signed. Exclusion Criteria: 1. Non-atherosclerotic intracranial artery stenosis, including arterial dissection; moya moya disease; systemic vasculitis and primary central nervous system vasculitis; varicella-zoster vasculopathy or other viral vasculopathy; neurosyphilis and other intracranial infections, radiation vasculopathy; fibromuscular dysplasia, sickle cell disease, neurofibromatosis; rever