PCSK9 Inhibitor for Intracranial Atherosclerosis Related Acute Ischemic Stroke

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.

Conditions

• Acute Ischemic Stroke AIS
• Intracranial Atherosclerosis ICAS
• Atherosclerotic Plaque

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."

Sponsors & Collaborators

• Chinese PLA General Hospital

  collaborator OTHER

• Hebei General Hospital

  collaborator OTHER

• Taihe Hospital

  collaborator OTHER

• Weifang People's Hospital

  collaborator OTHER

• Nanjing First Hospital, Nanjing Medical University

  collaborator OTHER

• Baotou Central Hospital

  collaborator OTHER

• Jining First People's Hospital

  collaborator OTHER

• Liaocheng People's Hospital

  collaborator OTHER

• Tangshan Worker's Hospital

  collaborator OTHER

• Chongqing General Hospital

  collaborator OTHER

• First Affiliated Hospital of Harbin Medical University

  collaborator OTHER

• Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine

  collaborator OTHER

• The First Affiliated Hospital of Zhengzhou University

  collaborator OTHER

• The Affiliated Hospital of Qingdao University

  collaborator OTHER

• Zhongnan Hospital

  collaborator OTHER

• Huashan Hospital

  collaborator OTHER

• Peking Union Medical College Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

30 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-09-01

Primary Completion

2028-12-31

Completion

2029-12-31

Countries

• China

Study Locations