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Clinical Trials in China / NCT06902740
Recruiting Phase 4

PCSK9 Inhibitor With Statin Therapy for Asymptomatic Intracranial Atherosclerosis

NCT06902740 · tracked via the Priya Life Science China tracker
Sponsor
Peking Union Medical College Hospital
Phase
Phase 4
Started
2025-11-07
Last updated
2026-06-12

Condition(s) studied

Intracranial AtherosclerosisIntracranial Artery StenosisAtherosclerotic Plaque

Investigational drug(s) / intervention(s)

Recaticimab and StatinStatin

Recaticimab and Statin: Recaticimab (450mg every 12 weeks subcutaneously) combined with rosuvastatin 10mg qn or atorvastatin 20mg qn

Statin: Rosuvastatin 10mg qn or atorvastatin 20mg qn

Study summary

This is a prospective, multicenter, open-label, blinded-endpoint, randomized controlled trial designed to evaluate the efficacy and safety of PCSK9 inhibitor combined with statin therapy compared to statin monotherapy in reversing asymptomatic intracranial atherosclerosis, assessed using high-resolution magnetic resonance imaging of the intracranial vessel walls.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: 1. Age ≥18 and ≤80, male or female; 2. Asymptomatic intracranial artery stenosis (50%-99%) in the internal carotid artery (C6-7 segments), middle cerebral artery (M1 segment), vertebral artery (V4 segment), or basilar artery, confirmed by angiography (MRA, CTA, or DSA); 3. Atherosclerosis identified as the cause of intracranial artery stenosis by high-resolution magnetic resonance imaging; 4. No previous ischemic cerebrovascular events (including ischemic stroke or transient ischemic attack). 5. Baseline low-density lipoprotein cholesterol ≥ 1.8 mmol/L; 6. Informed consent signed. Exclusion Criteria: 1. Non-atherosclerotic intracranial artery stenosis, including arterial dissection; moya moya disease; systemic vasculitis and primary central nervous system vasculitis; varicella-zoster vasculopathy or other viral vasculopathy; neurosyphilis and other intracranial infections, radiation vasculopathy; fibromuscular dysplasia, sickle cell disease, neurofibromatosis; reversible cerebral vasoconstriction syndrome; postpartum vasculopathy; suspected vasospasm, suspected reperfusion after vessel occlusion. 2. Upstream tandem extracranial vessel stenosis (≥50%) adjacent to the target intracranial stenotic vessel. 3. Previous treatment of target intracranial lesion with endovascular intervention or plan to perform endovascular intervention within 6 months, including intracranial stenting, endovascular angioplasty, and thrombectomy. 4. Any intracranial hemorrhage (parenchymal, subarachnoid, subdural, extradural, intraventricular) within 90 days prior to enrollment. 5. Presence of intracranial tumors. 6. Presence of cerebral aneurysms or arteriovenous malformations with indications for interventional therapy. 7. Major surgery (including open femoral, aortic, or carotid surgery) within previous 30 days or planned in the next 6 months after enrollment. 8. Presence of any of the following unequivocal cardiac sources of embolism: mitral stenosis, mechanical valve, endocarditis, intracardiac clot or vegetation, myocardial infarction within 3 months, dilated cardiomyopathy, chronic or paroxysmal atrial fibrillation. 9. New York Heart Association (NYHA) class III or IV, or known left ventricular ejection fraction \< 30%. 10. Severe liver dysfunction or severe kidney dysfunction: AST and/or ALT \> 3 times the ULN; creatinine clearance \< 0.6 mL/s and/or serum creatinine \> 265 μmol/L (\>3.0 mg/dL); CK \>5 times the ULN at screening. 11. Active bleeding diathesis or coagulopathy (e.g., active peptic ulcer disease, major systemic hemorrhage within 30 days, active bleeding diathesis, platelets count \< 125,000 / uL, hematocrit \< 30%, Hgb \< 10 g/dl, international normalized ratio \>1.5, bleeding time \> 1 minute beyond normal value upper limit). 12. Presence of systemic autoimmune diseases: systemic sclerosis, systemic lupus erythematosus, Sjögren's syndrome, Behçet's disease, mixed connective tissue disease, IgG4-related disease. 13. Dementia or psychiatric problem that hinder their ability to consistently adhere to an outpatient program. Co-morbid conditions that may limit the life expectancy to less than 3 years. 14. Relative/absolute contraindications to magnetic resonance imaging (MRI) (such as presence of internal metallic objects, claustrophobia, contrast agent allergy, severe renal impairment, epilepsy, hypotension, asthma, and other hypersensitivity respiratory diseases). 15. Uncontrolled hypertension during the screening period, defined as seated systolic blood pressure (SBP) \> 180 mmHg or diastolic blood pressure (DBP) \> 110 mmHg. 16. Prior use of PCSK9 inhibitor before this recruitment. 17. Known intolerance or allergy to statin. 18. Pregnancy, lactation, or planning pregnancy. 19. Currently participating in another study.

Primary outcome measure(s)

Trial sites (19)

FacilityCityRegionStatus
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College Beijing Beijing Municipality Recruiting
Chinese PLA General Hospital Beijing Beijing Municipality Not Yet Recruiting
The Third Affiliated Hospital of Sun Yat-sen University, Yuedong Hospital Meizhou Guangdong Not Yet Recruiting
Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine Cangzhou Hebei Not Yet Recruiting
Peking University Third Hospital Qinhuangdao Hospital Qinhuangdao Hebei Not Yet Recruiting
Hebei Provincial People's Hospital Shijiazhuang Hebei Recruiting
Tangshan Worker's Hospital Tangshan Hebei Not Yet Recruiting
First Affiliated Hospital of Harbin Medical University Harbin Heilongjiang Not Yet Recruiting
The first affiliated hospital of zhengzhou university Zhengzhou Henan Not Yet Recruiting
Taihe Hospital Shiyan Hubei Not Yet Recruiting
Zhongnan Hospital of Wuhan University Wuhan Hubei Not Yet Recruiting
Baotou Central Hospital Baotou Inner Mongolia Not Yet Recruiting
Nanjing First Hospital Nanjing Jiangsu Not Yet Recruiting
Jining First People's Hospital Jining Shandong Not Yet Recruiting
Liaocheng People's Hospital Liaocheng Shandong Not Yet Recruiting
The Affiliated Hospital of Qingdao University Qingdao Shandong Not Yet Recruiting
Weifang People's Hospital Weifang Shandong Not Yet Recruiting
Chongqing General Hospital Chongqing China Not Yet Recruiting
Huashan Hospital, Fudan University Shanghai China Not Yet Recruiting

More Peking Union Medical College Hospital trials in China

Other trials for the same condition

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 NCT06902740 on ClinicalTrials.gov ↗ ← All trials in China