EARTH: EARly Prevention of aTHeroma Progression

Sponsor

CHEOL WHAN LEE, M.D., Ph.D (Other)

Overall Status

Terminated

CT.gov ID

NCT02105623

Collaborator

CardioVascular Research Foundation, Korea (Other)

111

Enrollment

Location

Arms

Actual Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Coronary Arteriosclerosis	Behavioral: Standard Therapy Drug: Rosuvastatin	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

111 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

EARly Prevention of aTHeroma Progression

Actual Study Start Date :

Jun 1, 2014

Actual Primary Completion Date :

Mar 1, 2018

Actual Study Completion Date :

Mar 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Standard Therapy Risk factor control Diet Exercise	Behavioral: Standard Therapy Risk factor control Diet Exercise for 24months
Experimental: Rosuvastatin therapy Risk factor control Rosuvastatin	Drug: Rosuvastatin Risk factor control rosuvastatin 5mg/day for 24months

Arm

Intervention/Treatment

Active Comparator: Standard Therapy

Risk factor control Diet Exercise

Behavioral: Standard Therapy

Risk factor control Diet Exercise for 24months

Experimental: Rosuvastatin therapy

Risk factor control Rosuvastatin

Drug: Rosuvastatin

Risk factor control rosuvastatin 5mg/day for 24months

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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 TAV at region of interest [2years]
TAV at 24months-TAV at baseline
Change in overall CAC(coronary artery calcification) score [2years]
overall CAC score at 24months-overall CAC score at baseline
Change in number of segment of any coronary atherosclerotic plaques [2years]
Percent change from baseline in lipid levels [2years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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