High Dose Atorvastatin for Preventing Periprocedural Ischemic Brain Damage During Carotid Artery Stenting
- Conditions
- Carotid Artery Stenosis
- Interventions
- Registration Number
- NCT03079115
- Lead Sponsor
- Beijing Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 130
- ≥ 50% stenosis of internal carotid artery in symptomatic patients; or ≥ 70% stenosis of internal carotid artery in asymptomatic patients
- received statin therapy for ≥ 2weeks before inclusion
- nonatherosclerotic carotid disease (dissection, radiation-induced stenosis)
- received endovascular procedure within 30 days before inclusion
- CAS during the procedure of urgent endovascular therapy for acute ischaemic stroke
- need for oral anticoagulant therapy
- high risk of bleeding or contraindications to antiplatelet therapy (eg: platelet count <70 X 109/L)
- active hepatic disease or hepatic dysfunction, or aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 1.5 upper normal limit
- myopathy or increased creatine kinase (CK) > 2 upper normal limit
- renal failure with serum creatinine (Scr) > 3 mg/dl or 264μmol/L
- unable to undergo MRI because of claustrophobia or pacemaker
- pregnancy, lactation, or child bearing potential women without any effective contraception
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description High-dose Atorvastatin Arm High-dose Atorvastatin High dose Atorvastatin (80 mg QD from 3 days before to 3 days after carotid artery stenting, thereafter conventional dose of Atorvastatin with 20mg QD until 30 days after CAS) Conventional-dose Atorvastatin Arm Conventional-dose Atorvastatin Conventional dose Atorvastatin (20mg QD from 3 days before to 30 days after CAS)
- Primary Outcome Measures
Name Time Method brain damage 30 days composite incidence of new ischemic lesion on post-CAS cerebral DW-MRI, TIA or ischaemic stroke within 30 days after CAS
- Secondary Outcome Measures
Name Time Method ischemic brain damage-4 30 days composite incidence of TIA or ischaemic stroke within 30 days after CAS
ischemic brain damage-1 within 5 days incidence of new ischemic lesion on post-CAS DW-MRI
ischemic brain damage-2 within 5 days number of new lesions on post-CAS DW-MRI
ischemic brain damage-3 within 5 days incidence of new lesion \> 5 mm on post-CAS DW-MRI
death, any stroke, or myocardial infarction 30 days composite incidence of death, any stroke, or myocardial infarction within 30 days after CAS
Trial Locations
- Locations (1)
Beijing Hospital
🇨🇳Beijing, Beijing, China