This trial is active, not recruiting.

Condition coronary arteriosclerosis
Treatments standard therapy, rosuvastatin
Phase phase 4
Sponsor CHEOL WHAN LEE, M.D., Ph.D
Collaborator CardioVascular Research Foundation, Korea
Start date June 2014
End date October 2017
Trial size 111 participants
Trial identifier NCT02105623, AMCCV2013-09


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).

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
(Active Comparator)
Risk factor control Diet Exercise
standard therapy
Risk factor control Diet Exercise for 24months
Risk factor control Rosuvastatin
Risk factor control rosuvastatin 5mg/day for 24months

Primary Outcomes

Percent change in total atheroma volume(TAV)
time frame: 2 years

Secondary Outcomes

Change in PAV(Percent atheroma volume) at region of interest
time frame: 2years
Change in overall TAV
time frame: 2years
Change in TAV at region of interest
time frame: 2years
Change in overall CAC(coronary artery calcification) score
time frame: 2years
Change in number of segment of any coronary atherosclerotic plaques
time frame: 2years
Percent change from baseline in lipid levels
time frame: 2years

Eligibility Criteria

Male or female participants at least 35 years old.

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

Additional Information

Official title EARly Prevention of aTHeroma Progression
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Asan Medical Center.