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This study will evaluate the efficacy and safety of high-intensity rosuvastatin and moderate-intensity rosuvastatin/ezetimibe in ASCVD patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rosuvamibe Tab | Experimental | Rosuvastatin 10mg/Ezetimibe 10mg qd for 24 weeks |
|
| Monorova Tab | Active Comparator | Rosuvastatin 20mg qd for 24 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rosuvamibe | Drug | Rosuvastatin 10mg/Ezetimibe 10mg |
| |
| Monorova |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to week 12 in LDL-C level | Baseline, Week 12 |
| 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) |
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Inclusion Criteria:
Aged 19 to 75 years
Patients diagnosed with ASCVD (coronary artery disease)
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:
â‘ Severe renal disease (CrCL < 30mL/min: Cockcroft-gault formula or estimated GFR (MDRD) < 30mL/min/1.73m2)
â‘¡ ALT, AST > 3x ULN or history of active liver disease
â‘¢ 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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Seongnam | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37800112 | Derived | Choi H, Kang SH, Jeong SW, Yoon CH, Youn TJ, Song WH, Jeon DW, Lim SW, Lee JH, Cho SW, Chae IH, Kim CH. Lipid-Lowering Efficacy of Combination Therapy With Moderate-Intensity Statin and Ezetimibe Versus High-Intensity Statin Monotherapy: A Randomized, Open-Label, Non-Inferiority Trial From Korea. J Lipid Atheroscler. 2023 Sep;12(3):277-289. doi: 10.12997/jla.2023.12.3.277. Epub 2023 Aug 3. |
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| Drug |
Rosuvastatin 20mg |
|
| 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 |