Rosuvastatin/Ezetimibe Versus Rosuvastatin in ASCVD Patients With Type 2 DM

Study Overview
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Brief Summary
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This study will evaluate the efficacy and aafety of rosuvastatin/ezetimibe combination therapy vs. rosuvastatin monotherapy in atherosclerotic cardiovascular disease patients with type 2 diabetes mellitus

Official Title
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Efficacy and Safety of Rosuvastatin/Ezetimibe Combination Therapy Versus Rosuvastatin Monotherapy in Atherosclerotic Cardiovascular Disease (ASCVD) Patients With Type 2 Diabetes Mellitus (DM)

Conditions
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Atherosclerotic Cardiovascular Disease, Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: Rosuvamibe
* Drug: Monorova


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 19 and above Patient with type 2 diabetes taking oral diabetes medication for at least 3 months Patient diagnosed with ASCVD Myocardial Infarction (MI) Acute coronary syndrome (ACS) History of Coronary revascularization(Percutaneous Coronary Intervention, PCI) History of Coronary artery bypass graft surgery (CABG) or other arterial revascularization procedures Stroke or Transient ischemic attack (TIA) Peripheral Arterial Disease (PAD) Stable Angina Written informed consent Exclusion Criteria: Type 1 diabetes HbA1c > 8.5% at screening Fasting triglyceride ≥ 400 mg/dL at screening 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 Those participating in clinical trials of other drugs Other than the above who is deemed to be ineligible to participate in the trial by investigator

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to week 24 in LDL-C level |  | Baseline, Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to week 12 in LDL-C level |  | Baseline, Week 12 | 
| Change from baseline to week 12 and week 24 in total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), triglycerides (TG) |  | 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 Apolipoprotein A1, Apolipoprotein B, Apolipoprotein B48, and Apolipoprotein B/Apolipoprotein A1 |  | Baseline, Week 24 | 
| Change from baseline to week 12 and week 24 in glycosylated hemoglobin (HbA1c) |  | 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 | 
| Proportion of subjects achieving LDL-C < 55mg/dL |  | Baseline, Week 12, Week 24 | 
| Occurrence of MACCE (Major Adverse Cardiovascular and Cerebrovascular Event) |  | Up to 24 weeks |