PCSK9 Inhibitor With Statin Therapy for Asymptomatic Intracranial Atherosclerosis (PISTIAS-2): A Multicenter, Open-label, Blinded-endpoint, Randomized Controlled Trial
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.
• Age ≥18 and ≤60, male or female;
• 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);
• Atherosclerosis identified as the cause of intracranial artery stenosis by high-resolution magnetic resonance imaging;
• No previous ischemic cerebrovascular events (including ischemic stroke or transient ischemic attack).
• Baseline low-density lipoprotein cholesterol ≥ 2.6 mmol/L;
• Informed consent signed.