This study will evaluate the efficacy and safety of high-intensity rosuvastatin and moderate-intensity rosuvastatin/ezetimibe in ASCVD patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
270
Rosuvastatin 10mg/Ezetimibe 10mg
Rosuvastatin 20mg
Seoul National University Bundang Hospital
Seongnam, South Korea
Change from baseline to week 12 in LDL-C level
Time frame: Baseline, Week 12
Change from baseline to week 12 and week 24 in total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), triglycerides (TG), Non-HDL cholesterol, Apolipoprotein A1, and Apolipoprotein B
Time frame: Baseline, Week 12, Week 24
Change from baseline to week 12 and week 24 in high-sensitivity C-reactive protein (hs-CRP)
Time frame: Baseline, Week 12, Week 24
Change from baseline to week 12 and week 24 in fasting plasma glucose (FPG)
Time frame: Baseline, Week 12, Week 24
Change from baseline to week 12 and week 24 in homeostasis model assessment for insulin resistance (HOMA-IR)
Time frame: Baseline, Week 12, Week 24
Proportion of subjects achieving LDL-C < 70mg/dL
Time frame: Baseline, Week 12, Week 24
Occurrence of Statin-Associated Muscle Symptoms (SAMS)
Time frame: Up to 24 weeks
Proportion of subjects with CPK 4 x upper limit of normal (ULN) or 10 x ULN
Time frame: Baseline, Week 12, Week 24
Proportion of subjects with AST or ALT levels elevated to 4 x ULN or 10 x ULN
Time frame: Baseline, Week 12, Week 24
Occurrence of MACCE (Major Adverse Cardiovascular and Cerebrovascular Event)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Up to 24 weeks