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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03903029
Recruitment Status : Active, not recruiting
First Posted : April 4, 2019
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
Seoul National University Hospital

Study Description
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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.

Condition or disease Intervention/treatment
Dyslipidemias Drug: Low-dose (10mg) rosuvastatin

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
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Study Type : Observational [Patient Registry]
Actual Enrollment : 242 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: AssessmeNt of Efficacy of Low-dose rosuvaStatin in KoRean 4 Statin Benefit Groups Per 2013 ACC/AHA Guideline
Actual Study Start Date : October 10, 2014
Actual Primary Completion Date : July 5, 2015
Estimated Study Completion Date : December 5, 2019

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Low-dose (10mg) rosuvastatin
Four statin benefit groups per 2013 ACC/AHA guideline in Korea
 Drug: Low-dose (10mg) rosuvastatin
Low-dose (10mg) rosuvastatin in 4 statin benefit groups per 2013 ACC/AHA guideline
Other Name: Crestor


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Percentage reduction in other lipids [ Time Frame: 8 weeks ]
    Percent changes from baseline to 8 weeks in total cholesterol, high-density lipoprotein (HDL) cholesterol, triglyceride (TG), non-HDL cholesterol, apolipoprotein B, apolipoprotein A1

  2. Achievement of ≥50% reduction in LDL cholesterol [ Time Frame: 8 weeks ]
    Achievement of ≥50% reduction in LDL cholesterol with use of rosuvastatin 10 mg in 8 weeks


Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Four statin benefit groups per 2013 ACC/AHA guideline in Korean
Criteria

Inclusion Criteria:

  1. subjects with prior history of clinical ASCVD
  2. subjects with primary elevation of LDL cholesterol ≥190 mg/dL
  3. subjects with diabetes, age 40 to 75 years, and LDL cholesterol 70 to 189 mg/dL
  4. subjects without diabetes, age 40 to 75 years, LDL cholesterol 70 to 189 mg/dL, and with estimated 10-year ASCVD risk ≥7.5%.

Exclusion Criteria:

  1. history of significant statin-induced rhabdomyolysis or myopathy
  2. history of a significant hypersensitivity reaction to rosuvastatin
  3. uncontrolled diabetes mellitus (HbA1c >9%)
  4. uncontrolled hypertension (systolic blood pressure >190 mmHg or diastolic blood pressure >100 mmHg)
  5. current active liver disease (alanine aminotransferase and/or aspartate aminotransferase >2 times the upper limit of normal)
  6. chronic kidney disease (serum creatinine clearance <30 ml/min)
  7. creatine kinase levels >3 times the upper limit of normal
  8. use of prohibited concomitant therapies
  9. history of malignancy within the last 5 years
  10. women who were pregnant, breast-feeding or of childbearing potential without contraception
  11. subjects who would take any medication for purposes other than this trial within 30 days after taking this study's medication.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03903029


Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Study Chair: Hyo-Soo Kim, MD., PhD. Seoul National University Hospital
More Information
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Additional Information:

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Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03903029    
Other Study ID Numbers: NewStaR4G
First Posted: April 4, 2019    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Seoul National University Hospital:
Cholesterol, LDL
Asian
Rosuvastatin
Low-dose
Additional relevant MeSH terms:
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Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
 Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors