EARly Prevention of aTHeroma Progression

NCT ID: NCT02105623

Last Updated: 2018-06-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 111 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2018-03-31

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).

Conditions

Coronary Arteriosclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard Therapy

Risk factor control Diet Exercise

Group Type: ACTIVE_COMPARATOR

Standard Therapy

Intervention Type: BEHAVIORAL

Risk factor control Diet Exercise for 24months

Rosuvastatin therapy

Risk factor control Rosuvastatin

Group Type: EXPERIMENTAL

Rosuvastatin

Intervention Type: DRUG

Risk factor control rosuvastatin 5mg/day for 24months

Interventions

Standard Therapy

Risk factor control Diet Exercise for 24months

Intervention Type: BEHAVIORAL

Rosuvastatin

Risk factor control rosuvastatin 5mg/day for 24months

Intervention Type: DRUG

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

• Minimum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CardioVascular Research Foundation, Korea

OTHER

Sponsor Role: collaborator

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

OTHER

Sponsor Role: lead

Responsible Party

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

MD

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Asan Medical Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

AMCCV2013-09

Identifier Type: -

Identifier Source: org_study_id