RecruitingPhase 4NCT06902740

PCSK9 Inhibitor With Statin Therapy for Asymptomatic Intracranial Atherosclerosis

PCSK9 Inhibitor With Statin Therapy for Asymptomatic Intracranial Atherosclerosis (PISTIAS-2): A Multicenter, Open-label, Blinded-endpoint, Randomized Controlled Trial

Sponsor

Peking Union Medical College Hospital

Enrollment

300 participants

Start Date

Nov 7, 2025

Study Type

INTERVENTIONAL

Conditions

Atherosclerotic Plaque Intracranial Atherosclerosis Intracranial Artery Stenosis

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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Recaticimab and Statin and a drug called Statin for people with atherosclerotic plaque, intracranial artery stenosis, and other related conditions. The study is currently recruiting participants at 19 locations. People eligible for this study include aged 18 Years to 80 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRecaticimab and Statin

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

DRUGStatin

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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06902740

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