Intracranial atherosclerotic diseases
Conditions
Interventions
Super intensive lipid-lowering treatment group:evolocumab(subcutaneous 140mg,every 2 weeks with a window of ± 3 days for each visit) and Rosuvastatin(20mg each day) or Atorvastatin (40mg qd) with or w
Traditional intensive lipid-lowering treatment group:Rosuvastatin(20mg each day) or Atorvastatin (40mg qd) with or without ezetimibe
Sponsors
Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
30 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age = 30 years and = 80 years. 2. Patients who suffered an ischemic stroke or TIA prior to enrollment: • Patients who suffered a TIA within 14 days prior to enrollment with a baseline ABCD2 score =4. • Patients who suffered an ischemic stroke within 14 days prior to enrollment with a baseline mRS score =3. 3. Qualifying event attributable to symptomatic intracranial atherosclerotic stenosis (50%-99%) of C6-7 cervical artery, middle cerebral artery (M1 segment), vertebral artery, or basilar artery that has been documented by magnetic resonance angiography or computed tomography angiography or digital subtraction angiography 4. The etiology of intracranial artery stenosis was identified as atherosclerosis diagnosed by high-resolution magnetic resonance imaging.
Exclusion criteria
Exclusion criteria: 1. Upstream tandem extracranial vessel stenosis (=50%) adjacent to the target intracranial stenotic vessel or an uncertain symptomatic vessel. 2. 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. 3. Patients who have undergone extracranial/intracranial endovascular intervention within 30 days prior to enrollment or are planning 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, cerebral aneurysms, or arteriovenous malformations at screening. 6. Presence of any of the following unequivocal cardiac sources of embolism: mitral stenosis, mechanical valve, endocarditis, intracardiac clot or vegetation, myocardial infarction within three months, dilated cardiomyopathy, chronic or paroxysmal atrial fibrillation, left atrial spontaneous echo contrast, ejection fraction less than 30%. 7. AST and/or ALT > 3 times the ULN; creatinine clearance 265 µmol/L (>3.0 mg/dL); CK >5 times the ULN at screening. 8. Retinal hemorrhage Active bleeding diathesis or coagulopathy; active peptic ulcer disease, major systemic hemorrhage within 30 days, active bleeding diathesis, platelets count 1.5, bleeding time >1 minute beyond ULN at screening, or heparin associated thrombocytopenia that increases the risk of bleeding 9. Major surgery (including open femoral, aortic, or carotid surgery) within previous 30 days or planned in the next 6 months after enrollment. 10. 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. 11. Pregnancy, lactation, or planning pregnancy. 12. Use of PCSK9 inhibitors or CETP inhibitors within 24 weeks prior to enrollment. 13. Presence of systemic autoimmune diseases: systemic sclerosis, systemic lupus erythematosus, Sjögren's syndrome, Behçet's disease, mixed connective tissue disease, IgG4-related disease. 14. Uncontrolled hypertension during the screening period, defined as seated systolic blood pressure (SBP) > 180 mmHg or diastolic blood pressure (DBP) > 110 mmHg. 15. New York Heart Association (NYHA) class III or IV, or known left ventricular ejection fraction < 30%. 16. 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). 17. Known intolerance to rosuvastatin OR known statin intolerance 18. Currently participating in another study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plaque burden; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time from randomization to first occurrence of ischemic stroke or TIA; | — |
Countries
China
Contacts
Public ContactWeihai Xu; Caiyan Liu
Department of Neurology, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences
Outcome results
None listed