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

Dyslipidemias Clinical Trial

Official title:

AssessmeNt of Efficacy of Low-dose rosuvaStatin in KoRean 4 Statin Benefit Groups Per 2013 ACC/AHA Guideline

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03903029
• Other study ID #: NewStaR4G
• Status: Active, not recruiting
• Start date: October 10, 2014
• Est. completion date: December 5, 2019

Study information

• Verified date: March 2019
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 242
• Est. completion date: December 5, 2019
• Est. primary completion date: July 5, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dyslipidemias

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	8 weeks
Secondary	Achievement of =50% reduction in LDL cholesterol	Achievement of =50% reduction in LDL cholesterol with use of rosuvastatin 10 mg in 8 weeks	8 weeks