High-intensity Rosuvastatin and Moderate-intensity Rosuvastatin/Ezetimibe in ASCVD Patients
NCT ID: NCT03494270
Last Updated: 2019-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
270 participants
INTERVENTIONAL
2018-03-18
2019-09-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Rosuvamibe Tab
Rosuvastatin 10mg/Ezetimibe 10mg qd for 24 weeks
Rosuvamibe
Rosuvastatin 10mg/Ezetimibe 10mg
Monorova Tab
Rosuvastatin 20mg qd for 24 weeks
Monorova
Rosuvastatin 20mg
Interventions
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Rosuvamibe
Rosuvastatin 10mg/Ezetimibe 10mg
Monorova
Rosuvastatin 20mg
Eligibility Criteria
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Inclusion Criteria
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
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
19 Years
75 Years
ALL
No
Sponsors
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Yuhan Corporation
INDUSTRY
Responsible Party
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Locations
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Seoul National University Bundang Hospital
Seongnam, , South Korea
Countries
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References
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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.
Other Identifiers
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YMC033
Identifier Type: -
Identifier Source: org_study_id