EARly Prevention of aTHeroma Progression

Study Overview
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Brief Summary
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The purpose of this study is to compare standard therapy (risk factor control, life style modification) versus standard therapy plus low-dose rosuvastatin therapy (5mg/day) on progression of coronary atherosclerosis in statin naive individuals who have mild CAD (nonobstructive coronary atherosclerotic plaques) and normal LDL (low-density lipoprotein) cholesterol levels(<130mg/dl).

Official Title
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EARly Prevention of aTHeroma Progression

Conditions
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Coronary Arteriosclerosis

Intervention / Treatment
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* Behavioral: Standard Therapy
* Drug: Rosuvastatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men or women at least 35 years of age Mild CAD (nonobstructive coronary atherosclerotic plaques, lumen narrowing <50%) and CAC score <300 in at least one segment of proximal or mid-portion of major epicardial coronary arteries LDL cholesterol <130mg/dl Exclusion Criteria: History of stable angina, or acute coronary syndrome History of transient ischemic attack, or stroke Chronic kidney disease (eGFR< 60ml/min) Diabetes mellitus with microvascular complications or insulin therapy Hypertriglyceridemia (triglyceride >500mg/dl) Any statin therapy in the past 4 weeks Planned cardiac surgery or planned major non-cardiac surgery within 6 months. Chronic disease requiring treatment with oral, intravenous, or intra-articular corticosteroids (use of topical, inhaled, or nasal corticosteroids is permissible). A diagnosis of cancer (other than superficial squamous or basal cell skin cancer) in the past 3 years or current treatment for the active cancer. Any clinically significant abnormality identified at the screening visit, physical examination, laboratory tests, or electrocardiogram which, in the judgment of the Investigator, would preclude safe completion of the study. Hepatic disease or biliary tract obstruction, or significant hepatic enzyme elevation (ALT or AST > 3 times upper limit of normal). History of adult asthma manifested by bronchospasm in the past 6 months, or currently taking regular anti-asthmatic medication(s). Unwillingness or inability to comply with the procedures described in this protocol. Positive pregnancy test (all female subjects of childbearing potential must have a urine ß-human chorionic gonadotropin(hCG) pregnancy test performed at Screening and/ or within 7 days prior to randomization) or is known to be pregnant or lactating. Hypersensitivity to Crestor Skeletal muscle disease Combination use with cyclosporine Galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption Combination use of protease inhibitor

Ages Eligible for Study
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Minimum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Therapy<br>Risk factor control Diet Exercise | Behavioral: Standard Therapy<br>* Risk factor control Diet Exercise for 24months<br>|
| Experimental: Rosuvastatin therapy<br>Risk factor control Rosuvastatin | Drug: Rosuvastatin<br>* Risk factor control rosuvastatin 5mg/day for 24months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change in total atheroma volume(TAV) | Percent change in total atheroma volume(TAV) at region of interest defined as(TAV at 24 months-TAV at baseline)/(TAV at baseline)x 100 | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in PAV(Percent atheroma volume) at region of interest | Change in PAV(Percent atheroma volume) at region of interest(PAV at 24months-PAV at baseline) | 2years | 
| Change in overall TAV | Sum of TAV in all coronary segments | 2years | 
| Change in TAV at region of interest | TAV at 24months-TAV at baseline | 2years | 
| Change in overall CAC(coronary artery calcification) score | overall CAC score at 24months-overall CAC score at baseline | 2years | 
| Change in number of segment of any coronary atherosclerotic plaques |  | 2years | 
| Percent change from baseline in lipid levels |  | 2years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary Arteriosclerosis, rosuvastatin