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 to high-intensity statin.
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 1:1 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
270
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.
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
% change of low-density lipoprotein cholesterol
%change of LDL-C = (LDL-C at 12 weeks) - (LDL-C at baseline)/LDL-C at baseline \* 100
Time frame: at 12 weeks
% change of serum cholesterol level
total cholesterol, LDL, HDL cholesterol, triglyceride (mg/dL)
Time frame: at 12 and 24 weeks
% change of high-sensitivity C-reactive protein
hs-CRP(mg/dL)
Time frame: at 12 and 24 weeks
% change of fasting glucose
fasting plasma glucose(mg/dL)
Time frame: at 12 and 24 weeks
% change of homeostatic model assessment for insulin resistance(HOMA-IR)
HOMA-IR = glucose \* insulin / 405(glucose mg/dL , insulin uIU/mL)
Time frame: at 12 and 24 weeks
proportion of participant with statin-associated muscle symptoms
occurrence of statin-associated muscle symptoms
Time frame: at 12 and 24 weeks
proportion of participant with creatinine phosphokinase elevation
proportion of CPK elevation ≥4 or ≥10 upper normal of limit
Time frame: at 12 and 24 weeks
proportion of participant with liver function test abnormality
proportion of AST/ALT elevation ≥4 or ≥10 upper normal of limit
Time frame: at 12 and 24 weeks
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proportion of participant with major adverse cardiovascular and cerebrovascular events(MACCE)
MACCE defined as a composite of the followings : cardiovascular death, acute myocardial infarction, unstable angina, stroke
Time frame: at 12 and 24 weeks