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| Name | Class |
|---|---|
| Novartis | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluvastatin extended release tablet | Experimental | Fluvastatin extended release tablet 80mg/day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluvastatin extended release tablet | Drug |
|
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| Measure | Description | Time Frame |
|---|---|---|
| carotid IMT | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| lipid variables:TC, TG, LDL-C, HDL-C, apo B, apo A-I | week 12 and 24 |
| Measure | Description | Time Frame |
|---|---|---|
| hs-CRP, Lp-PLA2, OPN and OPG. | week 12,24 and 52 |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiology department ,Beijing Anzhen hospital | Recruiting | Beijing | Beijing Municipality | 100029 | China |
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| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D050197 | Atherosclerosis |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000077340 | Fluvastatin |
| ID | Term |
|---|---|
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |