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RECRUITING
NCT06902740
PHASE4

PCSK9 Inhibitor With Statin Therapy for Asymptomatic Intracranial Atherosclerosis

Sponsor: Peking Union Medical College Hospital

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.

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

DRUG

Recaticimab and Statin

Recaticimab (450mg every 12 weeks subcutaneously) combined with rosuvastatin 10mg qn or atorvastatin 20mg qn

DRUG

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