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Combination therapy of ezetimibe with a low-dose statin is occasionally used to avoid statin-related side effects in clinical practice among patients with atherosclerotic cardiovascular disease. This approach is equivalent to high-dose statin therapy to decrease LDL cholesterol level by >50%, allowing such patients to achieve LDL cholesterol target. However, it remains uncertain whether combination therapy with ezetimibe and low-dose statin verse high-dose statin monotherapy similarily suppress atherosclerotic plaque inflammation. This study is to compare high-dose rosuvastatin versus low-dose rosuvastatin plus ezetimibe on carotid plaque inflammation in patients with acute coronary syndrome using 18F-fluorodeoxyglucose (18FDG) positron emission tomography (PET) imaging.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rosuvastatin | Active Comparator | rosuvastatin 20 mg once a day for 6 months |
|
| ezetimibe/rosuvastatin | Experimental | ezetimibe/rosuvastatin 10/5 mg once a day for 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| high-dose rosuvastatin | Drug | rosuvastatin 20 mg once a day for 6 months |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percent change in most-diseased segment (MDS)-tissue blood ratio (TBR) of the index vessel | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in MDS TBR | 6 months | |
| Change in whole vessel TBR within the index vessel | 6 months | |
| Change in whole vessel TBR of the aorta |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Seoul | South Korea | ||||
| Korea University Guro Hospital |
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| low-dose rosuvastatin plus ezetimibe |
| Drug |
ezetimibe/rosuvastatin 10/5 mg once a day for 6 months |
|
| 6 months |
| Change in total cholesterol | 6 months |
| Change in triglyceride | 6 months |
| Change in HDL-cholesterol | 6 months |
| Change in LDL-cholesterol | 6 months |
| Change in high sensitive C-reactive protein | 6 months |
| Seoul |
| South Korea |
| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000068718 | Rosuvastatin Calcium |
| D000069438 | Ezetimibe |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001384 | Azetidines |
| D001385 | Azetines |
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