Clinical Trial

PCSK9 Inhibitor for Intracranial Atherosclerosis Related Acute Ischemic Stroke

Study acronym: PISTIAS-3
Not Yet Recruiting Phase 4
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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.
Protocol Amendment History 1 change
critical Primary endpoint(s) modified 2026-07-16
Trial Details
NCT Number NCT07466251
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 Acute Ischemic Stroke AIS, Intracranial Atherosclerosis ICAS, Atherosclerotic Plaque
Enrollment 1,212 participants
Start Date 2026-09-01
Primary Completion 2028-12-31 (estimated)
Study Completion 2029-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-15