intracranial artery stenosis induced- ischemic stroke/transient ischemic attack
Conditions
Interventions
moderate-intensity group:Moderate-intensity statin therapy
high-intensity group:High-intensity statin therapy
Sponsors
Wuxi people’s Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age >= 18 years old; 2.Meeting either of the following conditions: Transient ischemic attack (TIA) within 3 days of onset with baseline ABCD2 score >= 4; Ischemic stroke within 3 days of onset (mRS score = 55 mg/dL (>=1.4 mmol/L); 5.Patients or their legally authorized representatives understand the purpose and requirements of the present study, and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1.Presence of ipsilateral tandem extracranial artery stenosis (>=50%) or undetermined responsible vessel; 2.Any known non-atherosclerotic intracranial artery stenosis, including but not limited to arterial dissection, moyamoya disease, vasculitis, viral vasculopathy, neurosyphilis, intracranial infection, radiation vasculopathy, fibromuscular dysplasia, sickle cell disease, neurofibromatosis, reversible cerebral vasoconstriction syndrome, postpartum angiopathy, vasospasm, suspected recanalization post vascular embolism; 3.Received endovascular treatment for intracranial/extracranial arteries within 30 days before enrollment or plan to receive endovascular treatment within 30 days (including angioplasty, endarterectomy, and mechanical thrombectomy); 4.Presence of intracranial hemorrhage, including parenchymal hemorrhage, subarachnoid hemorrhage, subdural hemorrhage, or epidural hemorrhage, except for intracranial microbleeds detected by SWI; 5.Presence of giant intracranial tumor, giant cerebral aneurysm, or arteriovenous malformation before enrollment; 6.Definite cardioembolic source in this episode: mitral stenosis, mechanical valve, endocarditis, intracardiac thrombus or vegetation, myocardial infarction within 3 months, dilated cardiomyopathy, atrial fibrillation, left atrial spontaneous echo contrast, ejection fraction 3 times the upper limit of normal; creatinine clearance rate 265 µmol/L (3.0 mg/dL); creatine kinase >5 times the upper limit of normal; 8.Active peptic ulcer, active bleeding tendency: international normalized ratio >1.5 after correction, bleeding time exceeding the upper limit by 1 minute, or increased bleeding risk due to heparin-induced thrombocytopenia; major systemic bleeding within 30 days before enrollment; 9.Surgery within 30 days before or after enrollment, including cardiac surgery, open femoral surgery, aortic, or carotid surgery; 10.Previous neurological or mental diseases affecting neurological function scores or prognostic scores; severe neurological deficits preventing the patient from living independently; diagnosed dementia or mental illness interfering with the patient's ability to complete the follow-up plan; 11.Life expectancy 185 mmHg or diastolic blood pressure >110 mmHg; 17.Participating in a study conflicting with the current one.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All-cause mortality within 30 days;Recurrence ischemic stroke/TIA within 30 days; | — |
Secondary
| Measure | Time frame |
|---|---|
| The incidence of drug discontinuation or dose reduction due to statin intolerance within 30 days;30-day stroke-related death;Laboratory tests;30-day mRS 0-2;30-day vascular related death;30-day composite vascular endpoints;The incidence of adverse events within 30 days;30-day mRS 0-4;30-day mRS 0-5;30-day favorable functional outcome (mRS score 0-1);30-day mRS 0-3;The proportion of patients with LDL-C <1.4mmol/L at 30-day after randomization; | — |
Countries
China
Contacts
Public ContactJiang Yongjun, Wu Li
Wuxi People’s Hospital
Outcome results
None listed