Coronary Arteriosclerosis
Conditions
Keywords
Coronary Arteriosclerosis, rosuvastatin
Brief summary
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).
Interventions
BEHAVIORALStandard Therapy
Risk factor control Diet Exercise for 24months
DRUGRosuvastatin
Risk factor control rosuvastatin 5mg/day for 24months
Sponsors
CardioVascular Research Foundation, Korea
CHEOL WHAN LEE, M.D., Ph.D
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent change in total atheroma volume(TAV) | 2 years | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in number of segment of any coronary atherosclerotic plaques | 2years | — |
| Percent change from baseline in lipid levels | 2years | — |
| Change in TAV at region of interest | 2years | TAV at 24months-TAV at baseline |
| Change in PAV(Percent atheroma volume) at region of interest | 2years | Change in PAV(Percent atheroma volume) at region of interest(PAV at 24months-PAV at baseline) |
| Change in overall TAV | 2years | Sum of TAV in all coronary segments |
| Change in overall CAC(coronary artery calcification) score | 2years | overall CAC score at 24months-overall CAC score at baseline |
Countries
South Korea
Outcome results
None listed