ASCVD
Conditions
Brief summary
This study will evaluate the efficacy and safety of high-intensity rosuvastatin and moderate-intensity rosuvastatin/ezetimibe in ASCVD patients.
Interventions
DRUGRosuvamibe
Rosuvastatin 10mg/Ezetimibe 10mg
DRUGMonorova
Rosuvastatin 20mg
Sponsors
Yuhan Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Aged 19 to 75 years 2. Patients diagnosed with ASCVD (coronary artery disease) * acute coronary syndrome * history of myocardial infarction (MI) * stable or unstable angina * history of coronary revascularization * stroke or transient ischemic attack (TIA) * peripheral arterial disease, history of peripheral arterial revascularization 3. Taking a stable dose of a statin or a lipid-lowering agent of ezetimibe over 4 weeks before randomization 4. Written informed consent
Exclusion criteria
1. Administration of other lipid lowering agents than statin or ezetimibe within 3 months prior to screening visit 2. Fasting triglyceride ≥ 400 mg/dL 3. History of muscular disease or rhabdomyolysis due to use of statin 4. Hypersensitive to rosuvastatin or ezetemibe 5. Contraindications stated in the SPC of rosuvastatin or rosuvastatin/ezetimibe including the following: ① Severe renal disease (CrCL \< 30mL/min: Cockcroft-gault formula or estimated GFR (MDRD) \< 30mL/min/1.73m2) ② ALT, AST \> 3x ULN or history of active liver disease ③ CPK \> 3x ULN 6. Administration of other investigational products within 30 days prior to screening visit 7. Other than the above who is deemed to be ineligible to participate in the trial by investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline to week 12 in LDL-C level | Baseline, Week 12 |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline to week 12 and week 24 in high-sensitivity C-reactive protein (hs-CRP) | Baseline, Week 12, Week 24 |
| Change from baseline to week 12 and week 24 in fasting plasma glucose (FPG) | Baseline, Week 12, Week 24 |
| Change from baseline to week 12 and week 24 in homeostasis model assessment for insulin resistance (HOMA-IR) | Baseline, Week 12, Week 24 |
| Proportion of subjects achieving LDL-C < 70mg/dL | Baseline, Week 12, Week 24 |
| 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 | Baseline, Week 12, Week 24 |
| Proportion of subjects with CPK 4 x upper limit of normal (ULN) or 10 x ULN | Baseline, Week 12, Week 24 |
| Proportion of subjects with AST or ALT levels elevated to 4 x ULN or 10 x ULN | Baseline, Week 12, Week 24 |
| Occurrence of MACCE (Major Adverse Cardiovascular and Cerebrovascular Event) | Up to 24 weeks |
| Occurrence of Statin-Associated Muscle Symptoms (SAMS) | Up to 24 weeks |
Countries
South Korea
Outcome results
None listed