PCSK9 Inhibitor for Intracranial Atherosclerosis Related Acute Ischemic Stroke

NCT07466251 · tracked via the Priya Life Science China tracker

Sponsor

Peking Union Medical College Hospital

Phase

Phase 4

Started

2026-09-01

Last updated

2026-07-15

Condition(s) studied

Acute Ischemic Stroke AISIntracranial Atherosclerosis ICASAtherosclerotic Plaque

Investigational drug(s) / intervention(s)

Recaticimab plus standard therapy →Recaticimab's placebo in combination with standard therapy

Recaticimab 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's 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."

Study 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.

Eligibility

Sex

ALL

Min age

30 Years

Max age

80 Years

Healthy volunteers

Inclusion Criteria 1. Age 30 to 80 years, inclusive. 2. Acute ischemic stroke with symptom onset within 72 hours before screening, diagnosed on the basis of neurological deficits and CT or MRI findings. 3. National Institutes of Health Stroke Scale (NIHSS) score of 4 to 25 at hospital admission. 4. CTA, DSA, or MRA evidence that the culprit intracranial artery has atherosclerotic stenosis of 50% to 99%. Exclusion Criteria 1. Intracranial arterial stenosis attributable to a nonatherosclerotic cause, such as arterial dissection, moyamoya disease, or systemic vasculitis. 2. Any definite source of cardioembolism, such as atrial fibrillation, a mechanical prosthetic heart valve, left ventricular thrombus, or patent foramen ovale. 3. Clinical and imaging findings suggesting that the index ischemic event is primarily attributable to cerebral small vessel disease. 4. Pre-stroke disability, defined as a modified Rankin Scale score of 2 or higher before the index ischemic event. 5. 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. 6. Previous stent implantation in the culprit vessel or planned stent implantation in the culprit vessel within 3 months after enrollment. 7. Any intracranial hemorrhage within 3 months before enrollment. 8. An intracranial tumor; or a cerebral aneurysm or arteriovenous malformation judged to require interventional treatment. 9. Severe active bleeding tendency or coagulation disorder. 10. Severe cardiac, hepatic, renal, or other major organ dysfunction. 11. 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. 12. A definite contraindication to statin therapy or a history of statin intolerance. 13. Pregnant or breastfeeding, or planning to become pregnant during the study. 14. Current participation in another clinical trial.

Primary outcome measure(s)

Proportion of participants with functional independence, defined as a modified Rankin Scale score of 0-2, at Day 90 — Day 90 (±7 days) after randomization
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.

Trial sites (19)

Facility	City	Region
Chinese PLA General Hospital	Beijing	Beijing Municipality
The Third Affiliated Hospital of Sun Yat-sen University, Yuedong Hospital	Meizhou	Guangdong
Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine	Cangzhou	Hebei
Peking University Third Hospital Qinhuangdao Hospital	Qinhuangdao	Hebei
Hebei Provincial People's Hospital	Shijiazhuang	Hebei
Tangshan Worker's Hospital	Tangshan	Hebei
First Affiliated Hospital of Harbin Medical University	Harbin	Heilongjiang
The first affiliated hospital of zhengzhou university	Zhengzhou	Henan
Affiliated Taihe Hospital of Hubei University of Medicine	Shiyan	Hubei
Zhongnan Hospital of Wuhan University	Wuhan	Hubei
Baotou Central Hospital	Baotou	Inner Mongolia
Nanjing First Hospital	Nanjing	Jiangsu
Jining First People's Hospital	Jining	Shandong
Liaocheng People's Hospital	Liaocheng	Shandong
The Affiliated Hospital of Qingdao University	Qingdao	Shandong
Weifang People's Hospital	Weifang	Shandong
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

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Other trials for the same condition

Digital Angiography-Derived Fractional Flow Assessment for Intracranial Stenosis Active, not recruiting

Effect of Balloon Angioplasty vs Stenting Following Residual Stenosis After Endovascular Treatment of Intracranial Atherosclerotic Acute Ischemic Stroke Recruiting

A Phase IIa Clinical Trial to Evaluate the Efficacy and Safety of Intravenous Infusion of hUC-MSCs in Patients With AIS Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07466251 on ClinicalTrials.gov ↗ ← All trials in China