Fluvastatin AmelIorates aTHerosclerosis Study

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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 .

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

Conditions
-----------------
Coronary Heart Disease, Atherosclerosis

Intervention / Treatment
-----------------
* Drug: Fluvastatin extended release tablet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fluvastatin extended release tablet<br>Fluvastatin extended release tablet 80mg/day | Drug: Fluvastatin extended release tablet<br> <br> * Other names: Lescol XL;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| carotid IMT |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lipid variables:TC, TG, LDL-C, HDL-C, apo B, apo A-I |  | week 12 and 24 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
statin, atherosclerosis, Coronary heart disease, OPN, OPG