DyslipidemiasNCT03903029
Efficacy of Low-dose (10 mg) Rosuvastatin in Korean 4 Statin Benefit Groups Per 2013 ACC/AHA Guideline
An observational study of Dyslipidemias, run by Seoul National University Hospital.
Trial summary
This study aimed to evaluate the efficacy of low-dose rosuvastatin (10 mg) in the 4 statin benefit groups requiring high- or moderate-intensity statin therapy according to the 2013 American College of Cardiology/American Heart Association guideline in Korean population. Read more about this study
- Who is it for?
- Ages 21 to 79 years
- Conditions the study is for
- Dyslipidemias
- What is being tested?
- Low-dose (10mg) rosuvastatin
- How many people
- 242 participants
- Where
- No sites listed yet
- Study dates
- 10 Oct 2014to 5 Dec 2019
- How long will I take part?
- 5 Years
- Phase
- Observational
- 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 21 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Four statin benefit groups per 2013 ACC/AHA guideline in Korean
Who may be able to join
- subjects with prior history of clinical ASCVD
- subjects with primary elevation of LDL cholesterol ≥190 mg/dL
- subjects with diabetes, age 40 to 75 years, and LDL cholesterol 70 to 189 mg/dL
- subjects without diabetes, age 40 to 75 years, LDL cholesterol 70 to 189 mg/dL, and with estimated 10-year ASCVD risk ≥7.5%.
Who cannot join
- history of significant statin-induced rhabdomyolysis or myopathy
- history of a significant hypersensitivity reaction to rosuvastatin
- uncontrolled diabetes mellitus (HbA1c >9%)
- uncontrolled hypertension (systolic blood pressure >190 mmHg or diastolic blood pressure >100 mmHg)
- current active liver disease (alanine aminotransferase and/or aspartate aminotransferase >2 times the upper limit of normal)
- chronic kidney disease (serum creatinine clearance <30 ml/min)
Show all 11Show fewer
- creatine kinase levels >3 times the upper limit of normal
- use of prohibited concomitant therapies
- history of malignancy within the last 5 years
- women who were pregnant, breast-feeding or of childbearing potential without contraception
- subjects who would take any medication for purposes other than this trial within 30 days after taking this study's medication.
About this study
Official title: AssessmeNt of Efficacy of Low-dose rosuvaStatin in KoRean 4 Statin Benefit Groups Per 2013 ACC/AHA Guideline
This study aimed to evaluate the efficacy of low-dose rosuvastatin (10 mg) in the 4 statin benefit groups requiring high- or moderate-intensity statin therapy according to the 2013 American College of Cardiology/American Heart Association guideline in Korean population.
Read the detailed description
The primary endpoint was percentage reduction in low-density lipoprotein (LDL) cholesterol. Secondary endpoints were percentage reduction in other lipids and achievement of ≥50% reduction in LDL cholesterol. Intention-to-treat analyses were performed.
- Conditions
- Dyslipidemias
- Being tested
- Low-dose (10mg) rosuvastatin
- Keywords
- Cholesterol, LDL, Asian, Rosuvastatin, Low-dose
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-dose (10mg) rosuvastatinDrug
Also called Crestor
Low-dose (10mg) rosuvastatin in 4 statin benefit groups per 2013 ACC/AHA guideline
| Study group | Role | What they receive |
|---|---|---|
| Low-dose (10mg) rosuvastatin | Four statin benefit groups per 2013 ACC/AHA guideline in Korea Receives: Drug: Low-dose (10mg) rosuvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage reduction in low-density lipoprotein (LDL) cholesterol
Percentage reduction in low-density lipoprotein (LDL) cholesterol from baseline to 8 weeks of treatment
Measured: 8 weeks
Secondary outcomes (2)
Percentage reduction in other lipids
Percent changes from baseline to 8 weeks in total cholesterol, high-density lipoprotein (HDL) cholesterol, triglyceride (TG), non-HDL cholesterol, apolipoprotein B, apolipoprotein A1
Measured: 8 weeks
Achievement of ≥50% reduction in LDL cholesterol
Achievement of ≥50% reduction in LDL cholesterol with use of rosuvastatin 10 mg in 8 weeks
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2019
- Study start10 Oct 2014
- Primary completion5 Jul 2016
- Study completion5 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DyslipidemiasStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 242 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyo-Soo Kim, Seoul National University Hospital
- Investigators
- Hyo-Soo Kim, MD., PhD., Study chair, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03903029
- Sponsor's protocol ID
- NewStaR4G
- Status last verified
- Apr 2026
- First submitted
- 3 Apr 2019
- Last updated
- 27 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim KJ, Yoon J, Won KH, Lim SW, Chae IH, Lee SY, Kim SW, Kim HS. Assessment of the Efficacy of Lowering LDL Cholesterol with Rosuvastatin 10 mg in Four Korean Statin Benefit Groups as per ACC/AHA Guidelines (NewStaR4G). J Clin Med. 2020 Mar 27;9(4):916. doi: 10.3390/jcm9040916.
PubMed 32230818
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AssessmeNt of Efficacy of Low-dose rosuvaStatin in KoRean 4 Statin Benefit Groups Per 2013 ACC/AHA Guideline
- ClinicalTrials.gov ID
- NCT03903029
- Acronym / sponsor ID
- NewStaR4G
- Conditions
- Dyslipidemias
- Keywords
- Cholesterol, LDL, Asian, Rosuvastatin, Low-dose
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 10 Oct 2014 (actual)
- Primary completion
- 5 Jul 2016 (actual)
- Study completion
- 5 Dec 2019 (actual)
- First posted
- 4 Apr 2019 (actual)
- 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.
This study aimed to evaluate the efficacy of low-dose rosuvastatin (10 mg) in the 4 statin benefit groups requiring high- or moderate-intensity statin therapy according to the 2013 American College of Cardiology/American Heart Association guideline in Korean population.
Detailed description
The primary endpoint was percentage reduction in low-density lipoprotein (LDL) cholesterol. Secondary endpoints were percentage reduction in other lipids and achievement of ≥50% reduction in LDL cholesterol. Intention-to-treat analyses were performed.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Low-dose (10mg) rosuvastatin | – | Drug: Low-dose (10mg) rosuvastatinFour statin benefit groups per 2013 ACC/AHA guideline in Korea |
Who may qualify
- Ages
- 21 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Four statin benefit groups per 2013 ACC/AHA guideline in Korean
Key inclusion criteria (4 listed)
- subjects with prior history of clinical ASCVD
- subjects with primary elevation of LDL cholesterol ≥190 mg/dL
- subjects with diabetes, age 40 to 75 years, and LDL cholesterol 70 to 189 mg/dL
- subjects without diabetes, age 40 to 75 years, LDL cholesterol 70 to 189 mg/dL, and with estimated 10-year ASCVD risk ≥7.5%.
Key exclusion criteria (11 listed)
- history of significant statin-induced rhabdomyolysis or myopathy
- history of a significant hypersensitivity reaction to rosuvastatin
- uncontrolled diabetes mellitus (HbA1c >9%)
- uncontrolled hypertension (systolic blood pressure >190 mmHg or diastolic blood pressure >100 mmHg)
- current active liver disease (alanine aminotransferase and/or aspartate aminotransferase >2 times the upper limit of normal)
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 |
|---|---|---|
| Low-dose (10mg) rosuvastatinAlso: CrestorLow-dose (10mg) rosuvastatin in 4 statin benefit groups per 2013 ACC/AHA guideline | Drug | Low-dose (10mg) rosuvastatin |
Primary outcome
Percentage reduction in low-density lipoprotein (LDL) cholesterol
Time frame: 8 weeks
Percentage reduction in low-density lipoprotein (LDL) cholesterol from baseline to 8 weeks of treatment
2 secondary outcomes
Percentage reduction in other lipids
Time frame: 8 weeks
Achievement of ≥50% reduction in LDL cholesterol
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Results publication: PubMed 32230818Kim KJ, Yoon J, Won KH, Lim SW, Chae IH, Lee SY, Kim SW, Kim HS. Assessment of the Efficacy of Lowering LDL Cholesterol with Rosuvastatin 10 mg in Four Korean Statin Benefit Groups as per ACC/AHA Guidelines (NewStaR4G). J Clin Med. 2020 Mar 27;9(4):916. doi: 10.3390/jcm9040916.
- Individual participant dataSharing planned: No
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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.
Hyo-Soo Kim, MD., PhD. study chair
Seoul National University Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Dyslipidemias, run by Seoul National University Hospital.
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 4 inclusion and 11 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: finished, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percentage reduction in low-density lipoprotein (LDL) cholesterol (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03903029, which also lists 1 linked publication.
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 27 Apr 2026.