Clinical trial NCT02105623: EARly Prevention of aTHeroma Progression
Official title: EARly Prevention of aTHeroma Progression
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Coronary Arteriosclerosis
Keywords: Coronary Arteriosclerosis
rosuvastatin
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: CardioVascular Research Foundation, Korea
First posted: 2014-04-07
Enrollment: 111
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Percent change in total atheroma volume(TAV)
timeFrame: 2 years
Secondary outcomes:
measure: Change in PAV(Percent atheroma volume) at region of interest
timeFrame: 2years
measure: Change in overall TAV
timeFrame: 2years
measure: Change in TAV at region of interest
timeFrame: 2years
measure: Change in overall CAC(coronary artery calcification) score
timeFrame: 2years
measure: Change in number of segment of any coronary atherosclerotic plaques
timeFrame: 2years
measure: Percent change from baseline in lipid levels
timeFrame: 2years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
References: