Status:
COMPLETED
Efficacy and Safety of Combination Therapy of Moderate-intensity Statin and Ezetimibe Compared to High-intensity Statin
Lead Sponsor:
Seoul National University Bundang Hospital
Collaborating Sponsors:
Yuhan Corporation
Conditions:
Cardiovascular Diseases
Eligibility:
All Genders
19-75 years
Phase:
PHASE4
Brief Summary
This study is a multicenter, randomized, open-label, parallel, phase IV trial. The purpose of this study efficacy and safety of combination therapy of moderate-intensity statin and ezetimibe compared...
Detailed Description
The study is planned to include 272 patients with a clinical atherosclerotic cardiovascular disease requiring optimal statin therapy. After enrollment, subjects are randomized into two groups in a 1:...
Eligibility Criteria
Inclusion
- Aged between 19 and 75 years
- 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
- Patients who have been taking lipid-lowering agents (statin or ezetimibe) for ≥4 weeks at the time of randomization
- Patients who gave informed consent
Exclusion
- Patients who have used lipid-lowering agents other than statin or ezetimibe within the last 3 months
- A serum triglyceride on fasting \>400 mg/dL
- A history of muscular symptoms or rhabdomyolysis due to the use of statin
- Hypersensitivity to rosuvastatin or ezetimibe
- 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
- Enrollment of other clinical trials within 30 days
- Any other issues that the treating physician assumes ineligible for participation in the trial
Key Trial Info
Start Date :
March 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 17 2019
Estimated Enrollment :
270 Patients enrolled
Trial Details
Trial ID
NCT04080310
Start Date
March 15 2018
End Date
September 17 2019
Last Update
March 20 2020
Active Locations (2)
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1
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea, 06511
2
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea, 13620