Coronary ArteriosclerosisPhase 4EARTHNCT02105623
EARly Prevention of aTHeroma Progression
A Phase 4 study testing Standard Therapy and Rosuvastatin in people with Coronary Arteriosclerosis, run by CHEOL WHAN LEE, M.D., Ph.D at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Coronary Arteriosclerosis
- What is being tested?
- Standard Therapy and Rosuvastatin
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2014to Mar 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Standard Therapy, Rosuvastatin
- Keywords
- Coronary Arteriosclerosis, rosuvastatin
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard TherapyBehavioural
Risk factor control Diet Exercise for 24months
RosuvastatinDrug
Risk factor control rosuvastatin 5mg/day for 24months
| Study group | Role | What they receive |
|---|---|---|
| Standard Therapy | Active comparator | Risk factor control Diet Exercise Receives: Behavioral: Standard Therapy |
| Rosuvastatin therapy | Experimental | Risk factor control Rosuvastatin Receives: Drug: Rosuvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Secondary outcomes (6)
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)
Measured: 2years
Change in overall TAV
Sum of TAV in all coronary segments
Measured: 2years
Change in TAV at region of interest
TAV at 24months-TAV at baseline
Measured: 2years
Change in overall CAC(coronary artery calcification) score
overall CAC score at 24months-overall CAC score at baseline
Measured: 2years
Change in number of segment of any coronary atherosclerotic plaques
Measured: 2years
Percent change from baseline in lipid levels
Measured: 2years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2014 (estimated)
- Study startJun 2014
- Primary completionMar 2018
- Study completionMar 2018
Why it stopped: Slow enrollement, Low Follow-up rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary ArteriosclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHEOL WHAN LEE, M.D., Ph.D
- Sponsor type
- University, hospital or other
- Collaborators
- CardioVascular Research Foundation, Korea
- Responsible party
- Sponsor-investigator, CHEOL WHAN LEE, M.D., Ph.D, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02105623
- Sponsor's protocol ID
- AMCCV2013-09
- Acronym
- EARTH
- Status last verified
- Jun 2018
- First submitted
- 3 Apr 2014
- Last updated
- 25 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: This is not a publicly funded trial.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EARly Prevention of aTHeroma Progression
- ClinicalTrials.gov ID
- NCT02105623
- Acronym / sponsor ID
- EARTH / AMCCV2013-09
- Conditions
- Coronary Arteriosclerosis
- Keywords
- Coronary Arteriosclerosis, rosuvastatin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow enrollement, Low Follow-up rate
- Enrolment
- 111 participants (actual)
- Lead sponsor
- CHEOL WHAN LEE, M.D., Ph.DUniversity, hospital or other
- Collaborators
- CardioVascular Research Foundation, Korea
- Study start
- Jun 2014 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 7 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Therapy | Active comparator | Behavioral: Standard TherapyRisk factor control Diet Exercise |
| Rosuvastatin therapy | Experimental | Drug: RosuvastatinRisk factor control Rosuvastatin |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (19 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard TherapyRisk factor control Diet Exercise for 24months | Behavioural | Standard Therapy |
| RosuvastatinRisk factor control rosuvastatin 5mg/day for 24months | Drug | Rosuvastatin therapy |
Primary outcome
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
6 secondary outcomes
Change in PAV(Percent atheroma volume) at region of interest
Time frame: 2years
Change in overall TAV
Time frame: 2years
Change in TAV at region of interest
Time frame: 2years
Change in overall CAC(coronary artery calcification) score
Time frame: 2years
Change in number of segment of any coronary atherosclerotic plaques
Time frame: 2years
Percent change from baseline in lipid levels
Time frame: 2years
Results and safety
The study was stopped early (reason given: Slow enrollement, Low Follow-up rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2018.
- Individual participant dataSharing planned: No. This is not a publicly funded trial.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Standard Therapy and Rosuvastatin in people with Coronary Arteriosclerosis, run by CHEOL WHAN LEE, M.D., Ph.D at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Slow enrollement, Low Follow-up rate). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change in total atheroma volume(TAV) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2018.