EARly Prevention of aTHeroma Progression

• Status: Terminated
• Trial end date: 2018-03-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CHEOL WHAN LEE, M.D., Ph.D
• Collaborator: CardioVascular Research Foundation, Korea
• Treatments: Rosuvastatin Calcium

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