Efficacy of Two Different Doses of Atorvastatin for Prevention of Periprocedural Ischemic Brain Damage in Chinese Patients Undergoing Carotid Artery Stenting (CAS)
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- brain damage
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 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
排除标准
- •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
研究组 & 干预措施
High-dose Atorvastatin Arm
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)
干预措施: High-dose Atorvastatin (Drug)
Conventional-dose Atorvastatin Arm
Conventional dose Atorvastatin (20mg QD from 3 days before to 30 days after CAS)
干预措施: Conventional-dose Atorvastatin (Drug)
结局指标
主要结局
brain damage
时间窗: 30 days
composite incidence of new ischemic lesion on post-CAS cerebral DW-MRI, TIA or ischaemic stroke within 30 days after CAS
次要结局
- ischemic brain damage-4(30 days)
- ischemic brain damage-1(within 5 days)
- ischemic brain damage-2(within 5 days)
- ischemic brain damage-3(within 5 days)
- death, any stroke, or myocardial infarction(30 days)
研究者
Jun Lu
Attending Physician; MD
Beijing Hospital