EARly Prevention of aTHeroma Progression (EARTH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02105623
Recruitment Status : Active, not recruiting
First Posted : April 7, 2014
Last Update Posted : January 5, 2018
CardioVascular Research Foundation, Korea
Information provided by (Responsible Party):
CHEOL WHAN LEE, M.D., Ph.D, Asan Medical Center

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 111 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: EARly Prevention of aTHeroma Progression
Study Start Date : June 2014
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  1. Percent change in total atheroma volume(TAV) [ Time Frame: 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 :
  1. Change in PAV(Percent atheroma volume) at region of interest [ Time Frame: 2years ]
    Change in PAV(Percent atheroma volume) at region of interest(PAV at 24months-PAV at baseline)

  2. Change in overall TAV [ Time Frame: 2years ]
    Sum of TAV in all coronary segments

  3. Change in TAV at region of interest [ Time Frame: 2years ]
    TAV at 24months-TAV at baseline

  4. Change in overall CAC(coronary artery calcification) score [ Time Frame: 2years ]
    overall CAC score at 24months-overall CAC score at baseline

  5. Change in number of segment of any coronary atherosclerotic plaques [ Time Frame: 2years ]
  6. Percent change from baseline in lipid levels [ Time Frame: 2years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02105623

Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
CardioVascular Research Foundation, Korea

Responsible Party: CHEOL WHAN LEE, M.D., Ph.D, MD, Asan Medical Center Identifier: NCT02105623     History of Changes
Other Study ID Numbers: AMCCV2013-09
First Posted: April 7, 2014    Key Record Dates
Last Update Posted: January 5, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: This is not a publicly funded trial.

Keywords provided by CHEOL WHAN LEE, M.D., Ph.D, Asan Medical Center:
Coronary Arteriosclerosis

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Plaque, Atherosclerotic
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Coronary Disease
Heart Diseases
Pathological Conditions, Anatomical
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors