Recaticimab plus standard therapyRecaticimab'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
No
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
Status
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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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.
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