EARly Prevention of aTHeroma Progression (EARTH)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Asan Medical Center
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
CHEOL WHAN LEE, M.D., Ph.D, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT02105623
First received: April 3, 2014
Last updated: July 22, 2014
Last verified: July 2014
  Purpose

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 Intervention Phase
Coronary Arteriosclerosis
Behavioral: Standard Therapy
Drug: Rosuvastatin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: EARly Prevention of aTHeroma Progression

Resource links provided by NLM:


Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • Percent change in total atheroma volume(TAV) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2years ] [ Designated as safety issue: No ]
    Change in PAV(Percent atheroma volume) at region of interest(PAV at 24months-PAV at baseline)

  • Change in overall TAV [ Time Frame: 2years ] [ Designated as safety issue: No ]
    Sum of TAV in all coronary segments

  • Change in TAV at region of interest [ Time Frame: 2years ] [ Designated as safety issue: No ]
    TAV at 24months-TAV at baseline

  • Change in overall CAC(coronary artery calcification) score [ Time Frame: 2years ] [ Designated as safety issue: No ]
    overall CAC score at 24months-overall CAC score at baseline

  • Change in number of segment of any coronary atherosclerotic plaques [ Time Frame: 2years ] [ Designated as safety issue: No ]
  • Percent change from baseline in lipid levels [ Time Frame: 2years ] [ Designated as safety issue: No ]

Estimated Enrollment: 320
Study Start Date: June 2014
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02105623

Locations
Korea, Republic of
Asan Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Cheol-whan Lee, MD       cheolwlee@amc.seoul.kr   
Contact: Jung-hee Ham, Research coordinator       cvcrc5@amc.seoul.kr   
Principal Investigator: Cheol-whan Lee, MD         
Sponsors and Collaborators
CHEOL WHAN LEE, M.D., Ph.D
AstraZeneca
  More Information

No publications provided

Responsible Party: CHEOL WHAN LEE, M.D., Ph.D, MD, Asan Medical Center
ClinicalTrials.gov Identifier: NCT02105623     History of Changes
Other Study ID Numbers: AMCCV2013-09
Study First Received: April 3, 2014
Last Updated: July 22, 2014
Health Authority: Korea: Ministry of Food and Drug Safety

Keywords provided by Asan Medical Center:
Coronary Arteriosclerosis
rosuvastatin

Additional relevant MeSH terms:
Arteriosclerosis
Atherosclerosis
Coronary Artery Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Cardiovascular Diseases
Coronary Disease
Heart Diseases
Vascular Diseases
Rosuvastatin
Anticholesteremic Agents
Antimetabolites
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014