Efficacy of Two Different Pre-Intervention Therapeutic Strategies With Clopidogrel and Atorvastatin for the Prevention of Cerebral Damage During Carotid Artery Stenting. Armyda-Caro Randomized Trial.
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Cerebral damage
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of two different loading doses of Clopidogrel and a reloading of Atorvastatin in the prevention of periprocedural ischemic brain damage in patients undergoing carotid angioplasty.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •symptomatic and asymptomatic patients with finding of significant carotid stenosis
排除标准
- •patients with acute injuries to the baseline MRI of the brain,
- •patients with active bleeding,
- •contraindications to statin therapy and MRI contraindications (pacemaker/claustrophobic).
研究组 & 干预措施
Antiplatelet before carotid artery stenting
Clopidogrel 600 mg after carotid artery stenting
干预措施: Clopidogrel (Drug)
Statin therapy before carotid artery stenting
Reloading dose of Atorvastatin (80 mg at 12 hours and 40 mg at 6-8 hours before carotid artery stenting) versus no reload.
干预措施: Atorvastatin (Drug)
结局指标
主要结局
Cerebral damage
时间窗: 30 days
Incidence of stroke at 30 days (defined as a neurologic deficit lasting\> 24 hours with MRI evidence of cerebral ischemic injury) or transient ischemic attack (TIA); - Evidence of new onset acute ischemic lesions on MRI-DWI brain after the procedure, even in the absence of specific neurological symptoms
次要结局
- Bleeding complications(30 days)
研究者
Patti Giuseppe
MD
Campus Bio-Medico University