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PCSK9 Inhibitor for Intracranial Atherosclerosis Related Acute Ischemic Stroke
Sponsor: Peking Union Medical College Hospital
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.
Official title: PCSK9 Inhibitor for Intracranial Atherosclerosis Related Acute Ischemic Stroke (PISTIAS-3): a Randomized, Double-blind, Placebo-controlled Trial
Key Details
Gender
All
Age Range
30 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
1212
Start Date
2026-09-01
Completion Date
2029-12-31
Last Updated
2026-03-12
Healthy Volunteers
No
Interventions
Rucacuzumab plus standard therapy
Recaticimab (450 mg single dose, subcutaneous injection) combined with standard therapy recommended by the AHA/ASA Guidelines for Early Management of Acute Ischemic Stroke 2026 and the Chinese Guidelines for Diagnosis and Treatment of Acute Ischemic Stroke 2023.
Recaticimab plus placebo in combination with standard therapy
The placebo and investigational ricaximab were identical in appearance, packaging, labeling, administration method, and dosing frequency, managed through a unified production and coding system. Standard treatment followed the recommendations outlined in the "AHA/ASA Guidelines for the Early Management of Acute Ischemic Stroke 2026" and the "Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2023."
Locations (19)
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
Affiliated Taihe Hospital of Hubei University of Medicine
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
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, Beijing 100730
Beijing, China
Chongqing General Hospital
Chongqing, China
Huashan Hospital, Fudan University
Shanghai, China