Acute Coronary Syndrome, Carotid Atherosclerotic Plaque With Inflammation
Conditions
Keywords
rosuvastatin, ezetimibe/rosuvastatin, carotid plaque inflammation, fluorodeoxyglucose F18, positron emission tomography
Brief summary
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.
Interventions
rosuvastatin 20 mg once a day for 6 months
DRUGlow-dose rosuvastatin plus ezetimibe
ezetimibe/rosuvastatin 10/5 mg once a day for 6 months
Sponsors
Yuhan Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. aged ≥ 19 years 2. acute coronary syndrome, carotid artery disease (diameter stenosis 20-50%), and at least one 18FDG uptake lesion in the carotid artery (target to background ratio (TBR) ≥ 1.6) by 18FDG PET/CT imaging 3. written consent
Exclusion criteria
1. previous history of carotid endarterectomy or stenting 2. schedule for cardiac or major surgery within the next 6 months 3. statin or ezetimibe therapy in the past 4 weeks 4. chronic disease needed to be treated with oral, intravenous, or intraarticular steroid 5. end-stage renal disease 6. chronic liver disease 7. history of cancers within the past 3 years 8. pregnant, breast-feeding or child-bearing potential 9. expected life expectancy within 2 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change in most-diseased segment (MDS)-tissue blood ratio (TBR) of the index vessel | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Change in whole vessel TBR within the index vessel | 6 months |
| Change in whole vessel TBR of the aorta | 6 months |
| Change in total cholesterol | 6 months |
| Change in MDS TBR | 6 months |
| Change in HDL-cholesterol | 6 months |
| Change in LDL-cholesterol | 6 months |
| Change in high sensitive C-reactive protein | 6 months |
| Change in triglyceride | 6 months |
Countries
South Korea
Outcome results
None listed