Pitavastatin Evaluation of Atherosclerosis Regression by Intensive Cholesterol-Lowering Therapy
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 试验地点
- 18
- 主要终点
- absolute changes in carotid intima-media thickness from baseline to final visit
研究概览
简要总结
This study is aimed to analyze the effects of aggressive and conventional lipid lowering therapy with Pravastatin on carotid intima-media thickness (IMT) in patients with hyperlipidemia and abnormal thickening of IMT.
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed as having hyperlipidemia
- •LDL-C at the time of enrollment is no less than 100
- •Common carotid IMT is 1.1 mm and over
排除标准
- •Received or planned to receive intervention on carotid arteries during the study period
- •Overt liver dysfunction (ALT; 100 IU/L and over)
- •Overt renal dysfunction (serum creatinine; 2.0 mg/dL and over)
- •Receiving Cyclosporin
- •Hyperreactive to Pitavastatin
- •During pregnancy or lactation
研究组 & 干预措施
1
Subjects are receiving Pitavastatin, starting at 2 mg, for 12 months. After administration, serum LDL-cholesterol should be kept between 100 and 80 mg/dL by controlling the dose of Pitavastatin or adding other anti-hyperlipidemia agents other than statins.
干预措施: Pitavastatin (Drug)
2
Subjects are receiving Pitavastatin, starting at 4 mg, for 12 months. After administration, serum LDL-cholesterol should be kept under 80 mg/dL by controlling the dose of Pitavastatin or adding other anti-hyperlipidemia agents other than statins.
干预措施: Pitavastatin (Drug)
结局指标
主要结局
absolute changes in carotid intima-media thickness from baseline to final visit
时间窗: 12 months
次要结局
- change in hs-CRP and IL-6(12 months)
- change in LDL-C, HDL-C, TG and RLP-C(12 months)
- new onset or recurrence of ischemic heart disease, heart failure, stroke and atherosclerosis obliterans(12 months)
- relative change in carotid intima-media thickness(12 months)
- sudden death(12 months)
- side effects(12 months)