High-intensity Rosuvastatin and Moderate-intensity Rosuvastatin/Ezetimibe in ASCVD Patients

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the efficacy and safety of high-intensity rosuvastatin and moderate-intensity rosuvastatin/ezetimibe in ASCVD patients.

Official Title
-----------------
A Randomized, Open, Parallel, Multicenter, Phase 4 Study to Compare High-intensity Rosuvastatin to Moderate-intensity Rosuvastatin/Ezetimibe in Atherosclerotic Cardiovascular Disease (ASCVD) Patients

Conditions
-----------------
ASCVD

Intervention / Treatment
-----------------
* Drug: Rosuvamibe
* Drug: Monorova


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 19 to 75 years 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 Taking a stable dose of a statin or a lipid-lowering agent of ezetimibe over 4 weeks before randomization Written informed consent Exclusion Criteria: Administration of other lipid lowering agents than statin or ezetimibe within 3 months prior to screening visit Fasting triglyceride ≥ 400 mg/dL History of muscular disease or rhabdomyolysis due to use of statin Hypersensitive to rosuvastatin or ezetemibe 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 Administration of other investigational products within 30 days prior to screening visit Other than the above who is deemed to be ineligible to participate in the trial by investigator

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rosuvamibe Tab<br>Rosuvastatin 10mg/Ezetimibe 10mg qd for 24 weeks | Drug: Rosuvamibe<br>* Rosuvastatin 10mg/Ezetimibe 10mg<br>|
| Active Comparator: Monorova Tab<br>Rosuvastatin 20mg qd for 24 weeks | Drug: Monorova<br>* Rosuvastatin 20mg<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to week 12 in LDL-C level |  | Baseline, Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Occurrence of Statin-Associated Muscle Symptoms (SAMS) |  | Up to 24 weeks | 
| 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 |