The purpose is to test whether a short-term, high-dose atorvastatin treatment (80mg once a daily (QD) from 3 days before to 3 days after CAS, then 20 mg QD until 30 days after CAS) is superior to conventional-dose atorvastatin treatment (20 mg QD from 3 days before to 30 days after CAS), in terms of efficacy for prevention of periprocedural ischemic brain damage in Chinese patients undergoing CAS.
Chinese patients with carotid stenosis scheduled for selective CAS will be randomized into two groups. The High-dose Atorvastatin group will receive Atorvastatin 80 mg QD from 3 days before to 3 days after CAS, then 20 mg QD until 30 days after CAS, while the Conventional-dose Atorvastatin group will receive Atorvastatin 20 mg QD from 3 days before to 30 days after CAS. All patients will receive cerebral diffusion-weighted (DW)-MRI within 7 days before CAS. Then, they will also receive repeated DW-MRI within 5 days after CAS. Efficacy for prevention of periprocedural ischemic brain damage of the two different Atorvastatin treatments will be compared, in terms of periprocedural incidence of transient ischemic attack (TIA)/ ischaemic stroke or new ischemic lesions on cerebral DW-MRI.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
130
high-dose Atorvastatin (80 mg QD from 3 days before to 3 days after CAS, and thereafter 20mg QD until 30 days after CAS)
conventional-dose Atorvastatin(20 mg QD from 3 days before to 30 days after CAS).
Beijing Hospital
Beijing, Beijing Municipality, China
RECRUITINGbrain damage
composite incidence of new ischemic lesion on post-CAS cerebral DW-MRI, TIA or ischaemic stroke within 30 days after CAS
Time frame: 30 days
ischemic brain damage-1
incidence of new ischemic lesion on post-CAS DW-MRI
Time frame: within 5 days
ischemic brain damage-2
number of new lesions on post-CAS DW-MRI
Time frame: within 5 days
ischemic brain damage-3
incidence of new lesion \> 5 mm on post-CAS DW-MRI
Time frame: within 5 days
ischemic brain damage-4
composite incidence of TIA or ischaemic stroke within 30 days after CAS
Time frame: 30 days
death, any stroke, or myocardial infarction
composite incidence of death, any stroke, or myocardial infarction within 30 days after CAS
Time frame: 30 days
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