The Efficacy of Lescol XL(Fluvastatin Extended Release 80 mg) on Atherosclerosis Progression in Patients With Newly Diagnosed Coronary Heart Disease
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- carotid IMT
研究概览
简要总结
The study is designed to assess the effect of statin on atherosclesrosis progression as well as to explore its potential mechanism besides lipid modifying , such as effect on inflammation and vascular calcification.
详细描述
Carotid IMT has been used in various studies (e.g. ASAP, ARBITER, METEOR) and is well accepted as a valid surrogate marker for atherosclerosis. The thickness of CIMT is significantly associated with the presence and the extent of coronary disease. Slower progression of atherosclerosis as measured by carotid ultrasound is also associated with a lower risk of nonfatal MI. In a meta analysis, for every 0.0 1-mm-per-year decrease in carotid IMT, there was a significant 18% reduction in the risk of nonfatal MI. Measurement of carotid IMT carries the advantage of being non-invasive and easy to use with a good degree of reproducibility.
Statins have been shown to slow the progression of atherosclerosis or even to induce regression of atherosclerosis. Change of carotid IMT by statins have been found to correlate with the extent of LDL-C reduction and HDL-C increase however non-lipid effects (e.g. effects on inflammation, calcification ) may also play a role in the beneficial effects of statins on atherosclerosis.Osteopontin (OPN), an acidic phosphoprotein, and osteoprotegerin (OPG), a member of the tumor necrosis factor-a receptor superfamily, have been recently demonstrated to modulate vascular calcification. Recent studies have shown an association of serum OPN and OPG levels with cardiovascular diseases and vulnerable carotid plaque .
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed coronary heart disease
- •One or more maximum IMT measurements of ≥1.1mm.
- •Age 45 to 70 years old
- •LDL-C≥130mg/dL
- •Not receiving regular lipid lowering treatment
- •Written Informed Consent
排除标准
- •Myocardial infarction as the first symptoms of coronary heart disease
- •Patients with known hypersensitivity to fluvastatin or any of the excipients
- •Pregnancy or lactation, or women of childbearing potential not using effective contraception
- •Known muscle disease or history of muscle disease (e.g. myopathy, myositis, rhabdomyolysis) and/or serum CK levels greater than 2 x upper limit of normal (ULN)
- •renal dysfunction
- •Active liver disease and/or serum transaminase levels (ALT, AST) greater than 2x ULN
- •Any conditions the investigator consider not suitable for long-term follow up
研究组 & 干预措施
Fluvastatin extended release tablet
Fluvastatin extended release tablet 80mg/day
干预措施: Fluvastatin extended release tablet (Drug)
结局指标
主要结局
carotid IMT
时间窗: 1 year
次要结局
- lipid variables:TC, TG, LDL-C, HDL-C, apo B, apo A-I(week 12 and 24)
研究者
Chang sheng Ma
director of cardiology department
Beijing Anzhen Hospital
