EARly Prevention of aTHeroma Progression (EARTH)

CHEOL WHAN LEE, M.D., Ph.D

Status and phase

Terminated

Phase 4

Conditions

Coronary Arteriosclerosis

Treatments

Drug: Rosuvastatin

Behavioral: Standard Therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT02105623

AMCCV2013-09

Details and patient eligibility

About

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).

Enrollment

111 patients

Sex

All

Ages

35+ years old

Volunteers

No 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