Actively Recruiting
PCSK9 Inhibitor With Statin Therapy for Asymptomatic Intracranial Atherosclerosis
Led by Peking Union Medical College Hospital · Updated on 2025-08-07
300
Participants Needed
19
Research Sites
173 weeks
Total Duration
On this page
Sponsors
P
Peking Union Medical College Hospital
Lead Sponsor
C
Chinese PLA General Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
PCSK9 Inhibitor With Statin Therapy for Asymptomatic Intracranial Atherosclerosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 60 years, male or female
- Asymptomatic intracranial artery stenosis (50%-99%) in specified major intracranial arteries confirmed by angiography
- Atherosclerosis identified as cause of intracranial artery stenosis by high-resolution MRI
- No previous ischemic stroke or transient ischemic attack
- Baseline LDL cholesterol at least 2.6 mmol/L
- Signed informed consent
You will not qualify if you...
- Non-atherosclerotic intracranial artery stenosis or other vascular diseases such as arterial dissection, moya moya disease, vasculitis, viral vasculopathy, neurosyphilis, radiation vasculopathy, fibromuscular dysplasia, sickle cell disease, neurofibromatosis, reversible cerebral vasoconstriction syndrome, postpartum vasculopathy, suspected vasospasm or reperfusion
- Upstream extracranial vessel stenosis of 50% or more near target vessel
- Prior or planned endovascular intervention on target lesion within 6 months
- Intracranial hemorrhage within 90 days before enrollment
- Presence of intracranial tumors, cerebral aneurysms, or arteriovenous malformations needing intervention
- Major surgery within past 30 days or planned in next 6 months
- Cardiac embolism sources like mitral stenosis, mechanical valves, endocarditis, intracardiac clot, recent myocardial infarction, dilated cardiomyopathy, atrial fibrillation
- NYHA class III or IV heart failure or left ventricular ejection fraction below 30%
- Severe liver or kidney dysfunction beyond defined thresholds
- Active bleeding disorders or coagulopathy
- Systemic autoimmune diseases such as systemic sclerosis, lupus, Sjögren's syndrome, Behçet's disease, mixed connective tissue disease, IgG4-related disease
- Dementia or psychiatric conditions impeding program adherence or life expectancy under 3 years
- Contraindications to MRI including metallic implants, claustrophobia, contrast allergies, severe renal impairment, epilepsy, hypotension, asthma, or other respiratory hypersensitivity
- Uncontrolled hypertension above specified blood pressure limits
- Prior PCSK9 inhibitor use before recruitment
- Known statin intolerance or allergy
- Pregnancy, lactation, or planning pregnancy
- Current participation in another study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 19 locations
1
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
2
Chinese PLA General Hospital
Beijing, Beijing Municipality, China, 100853
Not Yet Recruiting
3
The Third Affiliated Hospital of Sun Yat-sen University, Yuedong Hospital
Meizhou, Guangdong, China
Not Yet Recruiting
4
Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine
Cangzhou, Hebei, China
Not Yet Recruiting
5
Peking University Third Hospital Qinhuangdao Hospital
Qinhuangdao, Hebei, China
Not Yet Recruiting
6
Hebei Provincial People's Hospital
Shijiazhuang, Hebei, China, 050051
Actively Recruiting
7
Tangshan Worker's Hospital
Tangshan, Hebei, China, 063000
Not Yet Recruiting
8
First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Not Yet Recruiting
9
The first affiliated hospital of zhengzhou university
Zhengzhou, Henan, China
Not Yet Recruiting
10
Taihe Hospital
Shiyan, Hubei, China, 442000
Not Yet Recruiting
11
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China
Not Yet Recruiting
12
Baotou Central Hospital
Baotou, Inner Mongolia, China, 014000
Not Yet Recruiting
13
Nanjing First Hospital
Nanjing, Jiangsu, China, 210000
Not Yet Recruiting
14
Jining First People's Hospital
Jining, Shandong, China, 272000
Not Yet Recruiting
15
Liaocheng People's Hospital
Liaocheng, Shandong, China, 252000
Not Yet Recruiting
16
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Not Yet Recruiting
17
Weifang People's Hospital
Weifang, Shandong, China, 261000
Not Yet Recruiting
18
Chongqing General Hospital
Chongqing, China
Not Yet Recruiting
19
Huashan Hospital, Fudan University
Shanghai, China
Not Yet Recruiting
Research Team
W
Weihai Xu, MD
CONTACT
Y
Yiyang Liu, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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