Intracranial atherosclerotic stenosis
Conditions
Interventions
Control group:Statin Group
Experimental group:Recaticimab plus Statin Group
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1.Age >=18 and = 2.6 mmol/L; 6.Informed consent signed.
Exclusion criteria
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) within 90 days prior to enrollment. 5.Presence of intracranial tumors, presence of cerebral aneurysms, or arteriovenous malformations with indications for interventional therapy. 6.Major surgery (including open femoral, aortic, or carotid surgery) within previous 30 days or planned in the next 6 months after enrollment. 7.New York Heart Association (NYHA) class III or IV, or known left ventricular ejection fraction 1.5, bleeding time >1 minute beyond ULN at screening, or heparin associated thrombocytopenia that increases the risk of bleeding. 10.Presence of systemic autoimmune diseases: systemic sclerosis, systemic lupus erythematosus, Sjögren's syndrome, Behçet's disease, mixed connective tissue disease, IgG4-related disease. 11.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. 12.AST and/or ALT > 3 times the ULN; creatinine clearance 265 µmol/L (>3.0 mg/dL); CK >5 times the ULN at screening. 13.Uncontrolled hypertension during the screening period, defined as seated systolic blood pressure (SBP) > 180 mmHg or diastolic blood pressure (DBP) > 110 mmHg. 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.Prior use of PCSK9 inhibitor or cholesteryl ester transfer protein inhibitor before this recruitment. 16.Pregnancy, lactation, or planning pregnancy. 17.Known intolerance or allergy to statin. 18.Currently participating in another study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage change in plaque burden; | — |
Secondary
| Measure | Time frame |
|---|---|
| Ischemic stroke or transient ischemic attack;Major adverse cardiovascular events;Percentage change in stenosis degree;Changes in biomarkers of vascular brain injury and neurodegeneration;Percentage of patients who achieved LDL-C target; | — |
Countries
China
Contacts
Public ContactWeihai Xu
Peking Union Medical College Hospital
Outcome results
None listed