Efficacy and Safety of Combination Therapy of Moderate-intensity Statin and Ezetimibe Compared to High-intensity Statin
NCT ID: NCT04080310
Last Updated: 2020-03-20
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
2018-03-15
2019-09-17
Brief Summary
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The purpose of this study efficacy and safety of combination therapy of moderate-intensity statin and ezetimibe compared to high-intensity statin.
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Detailed Description
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After enrollment, subjects are randomized into two groups in a 1:1 manner. The combination therapy group will receive a single-pill combination of rosuvastatin 10 mg and ezetimibe 10 mg once daily.
The subjects in the intensive statin group will receive rosuvastatin 20 mg once daily.
Subjects will visit at weeks 12 and 24 to identify medication adherence and clinical side effects.
The primary endpoint of this study is a % change of low-density lipoprotein cholesterol at 12 weeks.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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combination therapy group
The combination therapy group will receive a single-pill combination of rosuvastatin 10 mg and ezetimibe 10 mg once daily.
Efficacy and safety of combination therapy of moderate-intensity statin and ezetimibe compared to high-intensity statin
This study is a multicenter, randomized, open-label, parallel, phase IV trial. The study is planned to include 272 patients with clinical ASCVD requiring optimal statin therapy.
After enrollment, subjects are randomized into two groups in a 1:1 manner. patients in combination therapy group(rosuvastation 10mg and ezetimibe 10mg daily) will be provided a fixed-dose single pill comibation and patients in the intensive statin group will receive rosuvastatin 20mg daily.
intensive statin group
The subjects in the intensive statin group will receive rosuvastatin 20 mg once daily.
Efficacy and safety of combination therapy of moderate-intensity statin and ezetimibe compared to high-intensity statin
This study is a multicenter, randomized, open-label, parallel, phase IV trial. The study is planned to include 272 patients with clinical ASCVD requiring optimal statin therapy.
After enrollment, subjects are randomized into two groups in a 1:1 manner. patients in combination therapy group(rosuvastation 10mg and ezetimibe 10mg daily) will be provided a fixed-dose single pill comibation and patients in the intensive statin group will receive rosuvastatin 20mg daily.
Interventions
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Efficacy and safety of combination therapy of moderate-intensity statin and ezetimibe compared to high-intensity statin
This study is a multicenter, randomized, open-label, parallel, phase IV trial. The study is planned to include 272 patients with clinical ASCVD requiring optimal statin therapy.
After enrollment, subjects are randomized into two groups in a 1:1 manner. patients in combination therapy group(rosuvastation 10mg and ezetimibe 10mg daily) will be provided a fixed-dose single pill comibation and patients in the intensive statin group will receive rosuvastatin 20mg daily.
Eligibility Criteria
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Inclusion Criteria
2. Presence of atherosclerotic cardiovascular disease Coronary artery disease
* History of acute coronary syndrome
* Stable or unstable angina
* History of coronary revascularization Stroke or TIA Peripheral arterial disease, history of peripheral arterial revascularization
3. Patients who have been taking lipid-lowering agents (statin or ezetimibe) for ≥4 weeks at the time of randomization
4. Patients who gave informed consent
Exclusion Criteria
2. A serum triglyceride on fasting \>400 mg/dL
3. A history of muscular symptoms or rhabdomyolysis due to the use of statin
4. Hypersensitivity to rosuvastatin or ezetimibe
5. Labeled contraindications to rosuvastatin or rosuvastatin Severe renal impairment (CrCl \<30 mL/min by Cockcroft-Gault formula or estimated GFR \<30 mL/min / 1.73 m2 by MDRD equation) ALT, AST ≥3 × ULN or active liver disease CPK ≥3 × ULN
6. Enrollment of other clinical trials within 30 days
7. Any other issues that the treating physician assumes ineligible for participation in the trial
19 Years
75 Years
ALL
No
Sponsors
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Yuhan Corporation
INDUSTRY
Seoul National University Bundang Hospital
OTHER
Responsible Party
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Si-Hyuck Kang
Principal Investigator
Locations
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Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Countries
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Other Identifiers
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YMC033
Identifier Type: -
Identifier Source: org_study_id
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