Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Yuhan Corporation | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| combination therapy group | Active Comparator | The combination therapy group will receive a single-pill combination of rosuvastatin 10 mg and ezetimibe 10 mg once daily. |
|
| intensive statin group | Other | The subjects in the intensive statin group will receive rosuvastatin 20 mg once daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Efficacy and safety of combination therapy of moderate-intensity statin and ezetimibe compared to high-intensity statin | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| % change of low-density lipoprotein cholesterol | %change of LDL-C = (LDL-C at 12 weeks) - (LDL-C at baseline)/LDL-C at baseline * 100 | at 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| % change of serum cholesterol level | total cholesterol, LDL, HDL cholesterol, triglyceride (mg/dL) | at 12 and 24 weeks |
| % change of high-sensitivity C-reactive protein | hs-CRP(mg/dL) |
Not provided
Inclusion Criteria:
Aged between 19 and 75 years
Presence of atherosclerotic cardiovascular disease Coronary artery disease
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 Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do | 06511 | South Korea | ||
| Seoul National University Bundang Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| at 12 and 24 weeks |
| % change of fasting glucose | fasting plasma glucose(mg/dL) | 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) | at 12 and 24 weeks |
| proportion of participant with statin-associated muscle symptoms | occurrence of statin-associated muscle symptoms | at 12 and 24 weeks |
| proportion of participant with creatinine phosphokinase elevation | proportion of CPK elevation ≥4 or ≥10 upper normal of limit | 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 | at 12 and 24 weeks |
| 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 | at 12 and 24 weeks |
| Seongnam-si |
| Gyeonggi-do |
| 13620 |
| South Korea |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided