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)

• Proportion of participants with functional independence, defined as a modified Rankin Scale score of 0-2, at Day 90

  The modified Rankin Scale (mRS) is a 7-category ordinal scale ranging from 0 (no symptoms) to 6 (death), with lower scores indicating better functional status. This outcome is the proportion of participants with an mRS score of 0-2, representing functional independence. Participants who die before the Day 90 assessment will be assigned an mRS score of 6. The assessment will be performed by trained assessors blinded to treatment allocation.

  Day 90 (±7 days) after randomization

Secondary Outcomes (12)

• Proportion of participants with an excellent functional outcome, defined as an mRS score of 0-1, at Day 90

  Day 90 (±7 days) after randomization

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

  Day 90 (±7 days) after randomization

• Incidence of any stroke through Day 90

  From randomization through Day 90

• Incidence of ischemic stroke through Day 90

  From randomization through Day 90

• Incidence of composite vascular events through Day 90

  From randomization through Day 90

Other Outcomes (14)

• Change from baseline in NIHSS score at 24 hours

  From baseline to 24 hours after randomization, with an allowable assessment window of -2 to +12 hours

• Cerebral infarct volume at Day 7 or hospital discharge

  Day 7 (±2 days) after randomization or at hospital discharge, whichever occurs first

• Cerebral perfusion parameters at Day 7 or hospital discharge

  Day 7 (±2 days) after randomization or at hospital discharge, whichever occurs first

Study Arms (2)

Recaticimab plus standard therapy group

EXPERIMENTAL

Recaticimab in combination with standard therapy

Drug: Recaticimab plus standard therapy

Recaticimab's placebo in combination with standard therapy group

PLACEBO COMPARATOR

Recaticimab's placebo in combination with standard therapy

Drug: Recaticimab's placebo in combination with standard therapy

Interventions

Recaticimab 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's 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's placebo in combination with standard therapy group

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 to 80 years, inclusive.
• Acute ischemic stroke with symptom onset within 72 hours before screening, diagnosed on the basis of neurological deficits and CT or MRI findings.
• National Institutes of Health Stroke Scale (NIHSS) score of 4 to 25 at hospital admission.
• CTA, DSA, or MRA evidence that the culprit intracranial artery has atherosclerotic stenosis of 50% to 99%.

You may not qualify if:

• Intracranial arterial stenosis attributable to a nonatherosclerotic cause, such as arterial dissection, moyamoya disease, or systemic vasculitis.
• Any definite source of cardioembolism, such as atrial fibrillation, a mechanical prosthetic heart valve, left ventricular thrombus, or patent foramen ovale.
• Clinical and imaging findings suggesting that the index ischemic event is primarily attributable to cerebral small vessel disease.
• Pre-stroke disability, defined as a modified Rankin Scale score of 2 or higher before the index ischemic event.
• Extensive cerebral infarction on CT or MRI, such as an Alberta Stroke Program Early CT Score (ASPECTS) below 6 or an infarct volume of 70 mL or greater.
• Previous stent implantation in the culprit vessel or planned stent implantation in the culprit vessel within 3 months after enrollment.
• Any intracranial hemorrhage within 3 months before enrollment.
• An intracranial tumor; or a cerebral aneurysm or arteriovenous malformation judged to require interventional treatment.
• Severe active bleeding tendency or coagulation disorder.
• Severe cardiac, hepatic, renal, or other major organ dysfunction.
• Treatment with a PCSK9 monoclonal antibody inhibitor within 1 month before enrollment or with a PCSK9-targeting small interfering RNA therapy within 6 months before enrollment.
• A definite contraindication to statin therapy or a history of statin intolerance.
• Pregnant or breastfeeding, or planning to become pregnant during the study.
• Current participation in another clinical trial.

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
• Zhongnan Hospital: 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
• 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: July 15, 2026

Record last verified: 2026-04

Locations

CN (19)