Atherosclerosis Clinical Trial
Official title:
The Efficacy of Lescol XL(Fluvastatin Extended Release 80 mg) on Atherosclerosis Progression in Patients With Newly Diagnosed Coronary Heart Disease
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.
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 .
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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