Efficacy of Low-dose (10 mg) Rosuvastatin in Korean 4 Statin Benefit Groups Per 2013 ACC/AHA Guideline

NCT03903029 | Completed

• 1 other identifier: NewStaR4G
• Study Type: observational
• Target: 242
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Dyslipidemias

Keywords

Cholesterol, LDL; Asian; Rosuvastatin; Low-dose

Outcome Measures

Primary Outcomes (1)

• Percentage reduction in low-density lipoprotein (LDL) cholesterol

  Percentage reduction in low-density lipoprotein (LDL) cholesterol from baseline to 8 weeks of treatment

  8 weeks

Secondary Outcomes (2)

• Percentage reduction in other lipids

  8 weeks

• Achievement of ≥50% reduction in LDL cholesterol

  8 weeks

Study Arms (1)

Low-dose (10mg) rosuvastatin

Four statin benefit groups per 2013 ACC/AHA guideline in Korea

Drug: Low-dose (10mg) rosuvastatin

Interventions

Low-dose (10mg) rosuvastatin DRUG

Low-dose (10mg) rosuvastatin in 4 statin benefit groups per 2013 ACC/AHA guideline

Also known as: Crestor

Low-dose (10mg) rosuvastatin

Eligibility Criteria

• Age: 21 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Four statin benefit groups per 2013 ACC/AHA guideline in Korean

You may qualify if:

• 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%.

You may not qualify if:

• 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)
• 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.

Sponsors & Collaborators

• Seoul National University Hospital: lead

Related Publications (1)

• 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.

  PMID: 32230818 RESULT

MeSH Terms

Conditions

Dyslipidemias

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Hyo-Soo Kim, MD., PhD.

  Seoul National University Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Internal Medicine

Study Record Dates

• First Submitted: April 3, 2019
• First Posted: April 4, 2019
• Study Start: October 10, 2014
• Primary Completion: July 5, 2016
• Study Completion: December 5, 2019
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share