Silent Cerebrovascular Lesion and Cognitive Decline Prevention in Atrial Fibrillation by Intensive Cholesterol Lowering in Elderly Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Neurocognitive function
研究概览
简要总结
In elderly patients with atrial fibrillation (AF) the presence of silent brain infarcts and neurocognitive deficit is high despite adequate treatment with oral anticoagulation. Atherosclerosis is considered to be a chronic inflammatory disease and thrombosis and inflammation are strongly correlated. Atrial fibrillation is linked with increased levels of inflammatory markers and intensive cholesterol lowering has proven to reduce inflammation. In a prospective double-blind randomized pilot-study we want to test the hypothesis, that addition of intensive cholesterol lowering treatment besides adequate oral anticoagulation will reduce cerebrovascular lesions and will be beneficial for neurocognitive status in elderly AF patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double
入排标准
- 年龄范围
- 68 Years 至 82 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elderly patients (>68 and <82 years) with atrial fibrillation and adequate oral anticoagulation therapy and cholesterol levels between 4,5 mmol/l and 7 mmol/l
排除标准
- •Indication for cholesterol lowering treatment according to Dutch CBO-cholesterol guidelines (2004)
结局指标
主要结局
Neurocognitive function
Cerebrovascular lesions on MRI
次要结局
- Level of inflammatory markers
- Level of hemostatic markers