The Multicenter Atorvastatin Plaque Stabilization (MAPS) Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Changes in cellular composition of carotid plaque.
研究概览
简要总结
The impact on cardiovascular events achieved by statin therapy seems to be mostly attributable to the cholesterol-lowering effect with a highly debated contribution of the lipid-independent pleiotropic effects. However, a short-term benefit has been documented for patients treated with statins in acute coronary syndromes and other clinical settings. These observations strengthened the hypothesis of additional, so-called pleiotropic actions of statins.
The investigators therefore sought to investigate how different lipid-lowering strategies (non-statin therapy, low-dose statin and high-dose statin) affects cellular composition of carotid plaque over a short-term period of three months. Specifically the investigators tried and dissect the LDL-C lowering impact on plaque cellular composition as compared to the lipid-independent contribution on plaque macrophage and smooth muscle cells.
详细描述
Patients (with Total Cholesterol (TC) ranging between 5.83-7.64 mmol/l), never treated with lipid lowering drugs, with symptomatic carotid stenosis >70% (NASCET criteria), and therefore eligible for carotid endarterectomy, were recruited. All patients were enrolled within 30 days from the clinical event, and randomized to one of three treatment groups. Each group, composed of 20 patients, received atorvastatin 10 mg/day (AT-10 group), or atorvastatin 80 mg/day (AT-80 group), or cholestyramine (Questran, Bristol Myer Squibb) 8 g/day plus sitosterol (Unilever) 2.5 g/day (C-S group) for three months prior to the vascular procedure. A placebo group was not included for ethical reasons due to the high cardiovascular risk profile in this population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic carotid stenosis > 70% (NASCET criteria)
- •Eligibility for carotid endarterectomy
- •Total cholesterol level between 5.83 and 7.64 mmol/L
- •Never treated with lipid lowering drugs
排除标准
- •Previous lipid lowering therapy
- •Total cholesterol <5.83 or >7.64 mmol/L
- •Evidence of chronic inflammatory disease (clinical and laboratory).
- •Patients at high risk for cerebrovascular events (i.e. ulcerated carotid plaque, recurrent TIAs).
研究组 & 干预措施
Atorvastatin 10 mg/day
Arm composed of 20 patients, receiving atorvastatin 10 mg/day
干预措施: Atorvastatin - Cholestyramine - Sitosterol (Drug)
Atorvastatin 80 mg/day
Arm composed of 20 patients, receiving atorvastatin 80 mg/day
干预措施: Atorvastatin - Cholestyramine - Sitosterol (Drug)
Cholestyramine - Sitosterol
Arm composed of 20 patients receiving cholestyramine 8 g/day plus sitosterol 2.5 g/day
干预措施: Atorvastatin - Cholestyramine - Sitosterol (Drug)
结局指标
主要结局
Changes in cellular composition of carotid plaque.
时间窗: Three months
次要结局
未报告次要终点