Comparison of High-dose Rosuvastatin Versus Low-dose Rosuvastatin Plus Ezetimibe on Carotid Plaque Inflammation in Patients With Acute Coronary Syndrome

• Status: Completed
• Trial end date: 2019-07-23
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yuhan Corporation
• Treatments: Ezetimibe; Rosuvastatin Calcium

Criteria

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