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临床试验/NCT01681199
NCT01681199Unknown4 期

The Efficacy of Lescol XL(Fluvastatin Extended Release 80 mg) on Atherosclerosis Progression in Patients With Newly Diagnosed Coronary Heart Disease

Beijing Anzhen Hospital1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2012年7月最近更新:
适应症
干预措施
相关药物

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

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

Experimental

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

发起方
Beijing Anzhen Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Chang sheng Ma

director of cardiology department

Beijing Anzhen Hospital

研究点 (1)

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