Back to resultsEARly Prevention of aTHeroma Progression (EARTH)
Primary Purpose
Coronary Arteriosclerosis
Status
Terminated
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Standard Therapy
Rosuvastatin
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Arteriosclerosis focused on measuring Coronary Arteriosclerosis, rosuvastatin
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
Sites / Locations
- Asan Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard Therapy
Rosuvastatin therapy
Arm Description
Risk factor control Diet Exercise
Risk factor control Rosuvastatin
Outcomes
Primary Outcome Measures
Percent change in total atheroma volume(TAV)
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
Change in PAV(Percent atheroma volume) at region of interest(PAV at 24months-PAV at baseline)
Change in overall TAV
Sum of TAV in all coronary segments
Change in TAV at region of interest
TAV at 24months-TAV at baseline
Change in overall CAC(coronary artery calcification) score
overall CAC score at 24months-overall CAC score at baseline
Change in number of segment of any coronary atherosclerotic plaques
Percent change from baseline in lipid levels
Full Information
NCT ID
NCT02105623
First Posted
April 3, 2014
Last Updated
June 21, 2018
Sponsor
CHEOL WHAN LEE, M.D., Ph.D
Collaborators
CardioVascular Research Foundation, Korea
1. Study Identification
Unique Protocol Identification Number
NCT02105623
Brief Title
EARly Prevention of aTHeroma Progression
Acronym
EARTH
Official Title
EARly Prevention of aTHeroma Progression
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Terminated
Why Stopped
Slow enrollement, Low Follow-up rate
Study Start Date
June 2014 (Actual)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
March 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
CHEOL WHAN LEE, M.D., Ph.D
Collaborators
CardioVascular Research Foundation, Korea
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Arteriosclerosis
Keywords
Coronary Arteriosclerosis, rosuvastatin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
111 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard Therapy
Arm Type
Active Comparator
Arm Description
Risk factor control Diet Exercise
Arm Title
Rosuvastatin therapy
Arm Type
Experimental
Arm Description
Risk factor control Rosuvastatin
Intervention Type
Behavioral
Intervention Name(s)
Standard Therapy
Intervention Description
Risk factor control Diet Exercise for 24months
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin
Intervention Description
Risk factor control rosuvastatin 5mg/day for 24months
Primary Outcome Measure Information:
Title
Percent change in total atheroma volume(TAV)
Description
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
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Change in PAV(Percent atheroma volume) at region of interest
Description
Change in PAV(Percent atheroma volume) at region of interest(PAV at 24months-PAV at baseline)
Time Frame
2years
Title
Change in overall TAV
Description
Sum of TAV in all coronary segments
Time Frame
2years
Title
Change in TAV at region of interest
Description
TAV at 24months-TAV at baseline
Time Frame
2years
Title
Change in overall CAC(coronary artery calcification) score
Description
overall CAC score at 24months-overall CAC score at baseline
Time Frame
2years
Title
Change in number of segment of any coronary atherosclerotic plaques
Time Frame
2years
Title
Percent change from baseline in lipid levels
Time Frame
2years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
This is not a publicly funded trial.
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EARly Prevention of aTHeroma Progression
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