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PCSK9 Inhibitor With Statin Therapy for Asymptomatic Intracranial Atherosclerosis
Sponsor: Peking Union Medical College Hospital
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.
Official title: PCSK9 Inhibitor With Statin Therapy for Asymptomatic Intracranial Atherosclerosis (PISTIAS-2): A Multicenter, Open-label, Blinded-endpoint, Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
300
Start Date
2025-09-01
Completion Date
2028-12-31
Last Updated
2025-08-07
Healthy Volunteers
No
Interventions
Recaticimab and Statin
Recaticimab (450mg every 12 weeks subcutaneously) combined with rosuvastatin 10mg qn or atorvastatin 20mg qn
Statin
Rosuvastatin 10mg qn or atorvastatin 20mg qn
Locations (19)
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, China
Chinese PLA General Hospital
Beijing, Beijing Municipality, China
The Third Affiliated Hospital of Sun Yat-sen University, Yuedong Hospital
Meizhou, Guangdong, China
Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine
Cangzhou, Hebei, China
Peking University Third Hospital Qinhuangdao Hospital
Qinhuangdao, Hebei, China
Hebei Provincial People's Hospital
Shijiazhuang, Hebei, China
Tangshan Worker's Hospital
Tangshan, Hebei, China
First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
The first affiliated hospital of zhengzhou university
Zhengzhou, Henan, China
Taihe Hospital
Shiyan, Hubei, China
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China
Baotou Central Hospital
Baotou, Inner Mongolia, China
Nanjing First Hospital
Nanjing, Jiangsu, China
Jining First People's Hospital
Jining, Shandong, China
Liaocheng People's Hospital
Liaocheng, Shandong, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Weifang People's Hospital
Weifang, Shandong, China
Chongqing General Hospital
Chongqing, China
Huashan Hospital, Fudan University
Shanghai, China