Cardiovascular Diseases
Conditions
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 to high-intensity statin.
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 1:1 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.
Interventions
DRUGEfficacy 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.
Sponsors
Yuhan Corporation
Seoul National University Bundang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Aged between 19 and 75 years 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
1. Patients who have used lipid-lowering agents other than statin or ezetimibe within the last 3 months 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| % change of low-density lipoprotein cholesterol | at 12 weeks | %change of LDL-C = (LDL-C at 12 weeks) - (LDL-C at baseline)/LDL-C at baseline \* 100 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| % change of high-sensitivity C-reactive protein | at 12 and 24 weeks | hs-CRP(mg/dL) |
| % change of fasting glucose | at 12 and 24 weeks | fasting plasma glucose(mg/dL) |
| % change of homeostatic model assessment for insulin resistance(HOMA-IR) | at 12 and 24 weeks | HOMA-IR = glucose \* insulin / 405(glucose mg/dL , insulin uIU/mL) |
| % change of serum cholesterol level | at 12 and 24 weeks | total cholesterol, LDL, HDL cholesterol, triglyceride (mg/dL) |
| proportion of participant with creatinine phosphokinase elevation | at 12 and 24 weeks | proportion of CPK elevation ≥4 or ≥10 upper normal of limit |
| proportion of participant with liver function test abnormality | at 12 and 24 weeks | proportion of AST/ALT elevation ≥4 or ≥10 upper normal of limit |
| proportion of participant with major adverse cardiovascular and cerebrovascular events(MACCE) | at 12 and 24 weeks | MACCE defined as a composite of the followings : cardiovascular death, acute myocardial infarction, unstable angina, stroke |
| proportion of participant with statin-associated muscle symptoms | at 12 and 24 weeks | occurrence of statin-associated muscle symptoms |
Countries
South Korea
Outcome results
None listed