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NOT YET RECRUITING
NCT07466251
PHASE4

PCSK9 Inhibitor for Intracranial Atherosclerosis Related Acute Ischemic Stroke

Sponsor: Peking Union Medical College Hospital

View on ClinicalTrials.gov

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

DRUG

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.

DRUG

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