Clinical Trial

PCSK9 Inhibitor With Statin Therapy for Asymptomatic Intracranial Atherosclerosis

Study acronym: PISTIAS-2
Recruiting Phase 4
View on ClinicalTrials.gov →
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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-03-24; most recent amendment 2026-06-10.
Status change: Not Yet Recruiting → Recruiting 2025-08-03
Trial Details
NCT Number NCT06902740
Lead Sponsor Peking Union Medical College Hospital
Collaborators: Chinese PLA General Hospital, Hebei General Hospital, Taihe Hospital, Weifang People's Hospital, Nanjing First Hospital, Nanjing Medical University, Baotou Central Hospital, Jining First People's Hospital, Liaocheng People's Hospital, Tangshan Worker's Hospital, Chongqing General Hospital, First Affiliated Hospital of Harbin Medical University, Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine, The First Affiliated Hospital of Zhengzhou University, The Affiliated Hospital of Qingdao University, Zhongnan Hospital, Huashan Hospital
Conditions Intracranial Atherosclerosis, Intracranial Artery Stenosis, Atherosclerotic Plaque
Enrollment 300 participants
Start Date 2025-11-07
Primary Completion 2027-12-31 (estimated)
Study Completion 2028-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-06-12