Phase 3 Study of Atorvastatin Effects on Carotid Atherosclerosis
试验速览
- 阶段
- 4 期
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Changes in carotid plaque composition as assessed by MRI and histology
研究概览
简要总结
Atherosclerosis is a disease in which the blood vessels become blocked by plaques (consisting of fat, calcification, and fibrous tissue), reducing blood flow to vital organs and tissues.Blockage of the carotid arteries in the neck is a major cause of stroke. One way of treating carotid atherosclerosis is with cholesterol-lowering drugs called statins. Statins have been shown to reduce the risk of coronary heart disease by 24-40% and risk pf stroke by 11-30%.The purpose of this study is to determine if short term treatment with atorvastatin causes early favorable changes in the plaques that block blood flow through the carotid arteries. These changes can be assessed 1) by taking pictures of the carotid arteries with MRI and Ultrasound before and after statin treatment, and 2) by special studies of the plaques removed from the carotid arteries by surgery.
详细描述
Candidates for bilateral carotid endarterectomy (CEA) who meet study criteria will provide informed consent before their randomization. Before the first CEA, the patient will have MRI, US, and EBCT exams of both carotids. The most occlusive plaque will be resected at the first CEA. The patient will then receive atorvastatin 80 mg/day for 3 months. Then the second CEA will be performed. Six weeks after the second CEA, the patient will have another MRI, US, and EBCT exam and at 6, 12, and 18 months thereafter. This protocol will allow comparison of the characteristics of the plaque that has been exposed to drug vs the plaque that has not been exposed. It will also allow monitoring the effect of drug on restenosis after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women
- •>18 yrs old
- •Expected to have an endarterectomy on each carotid artery
- •No contraindications for atorvastatin
- •Stable cardiovascular health
- •Lipid lowering treatment less than 6 mo duration
- •Diabetic included if diabetes is controlled
- •Patient is not claustrophobic
- •Patient has evaluable carotid plaques.
排除标准
- •Patient has had previous carotid endarterectomy,stenting, or other procedure
- •Unstable cardiovascular status
- •Hypersensitivity to statin therapy
- •Neck anatomy preventing acquiring bilateral evaluable plaques
- •Weight over 285 lbs.
研究组 & 干预措施
A
An untreated carotid plaque will be obtained at the first endarterectomy. Atorvastatin 80mg will be administered for 3 months. The contralateral (treated) plaque will be obtained at the second endarterectomy. Hence, each patient will be his/her own control
干预措施: Atorvastatin (Drug)
结局指标
主要结局
Changes in carotid plaque composition as assessed by MRI and histology
时间窗: 3 months
次要结局
- Changes content of cells, proteins and genes in carotid plaque(3 months)
- Changes in content of selected proteins and their encoding genes in carotid plaques(3 months)