Status:
RECRUITING
PCSK9 Inhibitor With Statin Therapy for Asymptomatic Intracranial Atherosclerosis
Lead Sponsor:
Peking Union Medical College Hospital
Collaborating Sponsors:
Chinese PLA General Hospital
Hebei General Hospital
Conditions:
Intracranial Atherosclerosis
Intracranial Artery Stenosis
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
Brief 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 s...
Detailed Description
Intracranial atherosclerotic stenosis (ICAS) is a leading cause of ischemic stroke worldwide, accounting for approximately 10-20% of all ischemic strokes in Europe and the United States, and up to 50%...
Eligibility Criteria
Inclusion
- Age ≥18 and ≤60, male or female;
- 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);
- Atherosclerosis identified as the cause of intracranial artery stenosis by high-resolution magnetic resonance imaging;
- No previous ischemic cerebrovascular events (including ischemic stroke or transient ischemic attack).
- Baseline low-density lipoprotein cholesterol ≥ 2.6 mmol/L;
- Informed consent signed.
Exclusion
- 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.
- Upstream tandem extracranial vessel stenosis (≥50%) adjacent to the target intracranial stenotic vessel.
- 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.
- Any intracranial hemorrhage (parenchymal, subarachnoid, subdural, extradural, intraventricular) within 90 days prior to enrollment.
- Presence of intracranial tumors.
- Presence of cerebral aneurysms or arteriovenous malformations with indications for interventional therapy.
- Major surgery (including open femoral, aortic, or carotid surgery) within previous 30 days or planned in the next 6 months after enrollment.
- 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.
- New York Heart Association (NYHA) class III or IV, or known left ventricular ejection fraction \< 30%.
- 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.
- 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).
- Presence of systemic autoimmune diseases: systemic sclerosis, systemic lupus erythematosus, Sjögren's syndrome, Behçet's disease, mixed connective tissue disease, IgG4-related disease.
- 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.
- 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).
- Uncontrolled hypertension during the screening period, defined as seated systolic blood pressure (SBP) \> 180 mmHg or diastolic blood pressure (DBP) \> 110 mmHg.
- Prior use of PCSK9 inhibitor before this recruitment.
- Known intolerance or allergy to statin.
- Pregnancy, lactation, or planning pregnancy.
- Currently participating in another study.
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06902740
Start Date
September 1 2025
End Date
December 31 2028
Last Update
August 7 2025
Active Locations (19)
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1
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, China, 100730
2
Chinese PLA General Hospital
Beijing, Beijing Municipality, China, 100853
3
The Third Affiliated Hospital of Sun Yat-sen University, Yuedong Hospital
Meizhou, Guangdong, China
4
Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine
Cangzhou, Hebei, China