CompletedNot Applicable

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

242 participantsStarted 2014-10-10

Plain-language 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.

Who can participate

Age range21 Years – 79 Years

SexALL

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Inclusion criteria

✓. 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%.

Exclusion criteria

✕. 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

What they're measuring

Percentage reduction in low-density lipoprotein (LDL) cholesterol

Timeframe: 8 weeks

Trial details

NCT IDNCT03903029

SponsorSeoul National University Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2016-07-05

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