PCSK9 Inhibitor for Intracranial Atherosclerosis Related Acute Ischemic Stroke

NCT07466251 | Not Yet Recruiting Phase 4 DMC

• 3 other identifiers: 1-24PJ26002024ZD052160582025013
• Study Type: interventional
• Target: 1,212
• Locations: 1 country
• Sites: 19

Brief 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

Intracranial Atherosclerosis ICAS; Atherosclerotic Plaque; Acute Ischemic Stroke AIS

Keywords

Intracranial Atherosclerosis; intracranial artery stenosis; atherosclerotic plaque; PCSK9 inhibitor; Recaticimab

Outcome Measures

Primary Outcomes (1)

• 90-day modified Rankin Scale (mRS) score of 0-2

  Scoring using the modified Rankin Scale (mRS)

  Day 90 of patient enrollment

Secondary Outcomes (7)

• 90-day modified Rankin Scale (mRS) score of 0-1

  Day 90 of patient enrollment

• Distribution of modified Rankin Scale (mRS) scores at 90 days

  Day 90 of patient enrollment

• Time from randomization to the first-ever stroke

  From randomization to Day 90 of enrollment

• Time from randomization to the first-ever ischemic stroke

  From randomization to Day 90 of enrollment

• Time from randomization to the occurrence of major adverse cardiovascular events

  From randomization to Day 90 of enrollment

Other Outcomes (6)

• NIHSS at 24 hours, 7 days, and discharge

  At 24 hours, 7 days, and at discharge

• Cerebral infarction volume or perfusion status at 7 days post-enrollment or at discharge

  At 7 days post-enrollment or upon discharge

• Inflammation levels at 7 days post-group assignment or at discharge

  At 7 days post-enrollment or upon discharge

Study Arms (2)

Recaticimab plus standard therapy group

EXPERIMENTAL

Recaticimab in combination with standard therapy

Drug: Rucacuzumab plus standard therapy

Recaticimab plus placebo in combination with standard therapy grop

PLACEBO COMPARATOR

Recaticimab plus placebo in combination with standard therapy

Drug: Recaticimab plus placebo in combination with standard therapy

Interventions

Rucacuzumab plus standard therapy DRUG

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 standard therapy group

Recaticimab plus placebo in combination with standard therapy DRUG

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."

Recaticimab plus placebo in combination with standard therapy grop

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>=30 and \<=80;2.Acute ischemic stroke within 72 hours of onset (as determined by CT/MRI in conjunction with neurological deficit symptoms)
• Acute ischemic stroke within 72 hours of onset (diagnosed by CT/MRI in conjunction with neurological deficit symptoms)
• NIHSS score of 4-25 at admission
• Imaging studies (CTA/DSA/MRA) support intracranial atherosclerosis as the cause of stroke, meeting one of the following criteria: i. The culprit vessel exhibits intracranial atherosclerotic stenosis (ICAS) with a narrowing degree of 50-99%; ii. The culprit vessel exhibits intracranial atherosclerotic occlusion (ICAS-LVO), with successful recanalization achieved via mechanical thrombectomy (immediate expanded thrombolysis in cerebral infarction \[eTICI\] grade 2b50-3)
• Informed consent signed

You may not qualify if:

• Non-atherosclerotic intracranial arterial stenosis (such as arterial dissection, Moyamoya disease, systemic vasculitis, etc.)
• Any identifiable source of cardiogenic embolism (such as atrial fibrillation, mechanical valves, left ventricular thrombus, patent foramen ovale, etc.)
• Imaging findings and clinical presentation suggest that the primary pathophysiology of this event is more consistent with cerebral small vessel disease (e.g., perforator artery occlusion/lacunar infarction)
• Pre-existing disability prior to this ischemic event (modified Rankin Scale ≥ 2 points)
• CT or MRI findings suggest extensive cerebral infarction (e.g., ASPECTS score \< 6 or infarct volume ≥ 70 ml)
• Has undergone or is scheduled to undergo a vascular stent implantation procedure within the next three months
• Any intracranial hemorrhage occurring within 3 months prior to enrollment;
• Intracranial tumors, cerebral aneurysms, or arteriovenous malformations that are assessed as having indications for interventional treatment
• Severe active bleeding tendency or coagulation disorder
• Severe dysfunction of vital organs such as the heart, liver, and kidneys
• Received PCSK9 monoclonal antibody inhibitor therapy within 1 month prior to enrollment or PCSK9 siRNA inhibitor therapy within 6 months prior to enrollment
• A clear contraindication to statins or a history of intolerance to them
• Pregnancy, breastfeeding, or planning pregnancy;14.Currently participating in another study

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead
• Chinese PLA General Hospital: collaborator
• Hebei General Hospital: collaborator
• Taihe Hospital: collaborator
• Weifang People's Hospital: collaborator
• Nanjing First Hospital, Nanjing Medical University: collaborator
• Baotou Central Hospital: collaborator
• Jining First People's Hospital: collaborator
• Liaocheng People's Hospital: collaborator
• Tangshan Worker's Hospital: collaborator
• Chongqing General Hospital: collaborator
• First Affiliated Hospital of Harbin Medical University: collaborator
• Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine: collaborator
• The First Affiliated Hospital of Zhengzhou University: collaborator
• The Affiliated Hospital of Qingdao University: collaborator
• Zhongnan Hospital: collaborator
• Huashan Hospital: collaborator

Study Sites (19)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

Location

The Third Affiliated Hospital of Sun Yat-sen University, Yuedong Hospital

Meizhou, Guangdong, China

Location

Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine

Cangzhou, Hebei, China

Location

Peking University Third Hospital Qinhuangdao Hospital

Qinhuangdao, Hebei, China

Location

Hebei Provincial People's Hospital

Shijiazhuang, Hebei, 050051, China

Location

Tangshan Worker's Hospital

Tangshan, Hebei, 063000, China

Location

First Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Location

The first affiliated hospital of zhengzhou university

Zhengzhou, Henan, China

Location

Affiliated Taihe Hospital of Hubei University of Medicine

Shiyan, Hubei, China

Location

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

Location

Baotou Central Hospital

Baotou, Inner Mongolia, 014000, China

Location

Nanjing First Hospital

Nanjing, Jiangsu, 210000, China

Location

Jining First People's Hospital

Jining, Shandong, 272000, China

Location

Liaocheng People's Hospital

Liaocheng, Shandong, 252000, China

Location

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Location

Weifang People's Hospital

Weifang, Shandong, 261000, China

Location

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, Beijing 100730

Beijing, China

Location

Chongqing General Hospital

Chongqing, China

Location

Huashan Hospital, Fudan University

Shanghai, China

Location

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  RESULT

MeSH Terms

Conditions

Plaque, Atherosclerotic; Intracranial Arteriosclerosis

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Weihai Xu, MD

CONTACT

86+13938912070; xuwh@pumch.cn

Yiyang Liu, PhD

CONTACT

86+13938912070; liuyydoct@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Subjects, clinical investigators, outcome assessors, imaging evaluators, laboratory technicians, data management personnel, and statistical analysts remained blinded to treatment allocation throughout the entire study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD & PhD

Study Record Dates

• First Submitted: March 7, 2026
• First Posted: March 12, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: March 12, 2026

Record last verified: 2026-03

Locations

CN (19)