Clinical trial NCT04056169: Comparison of High-dose Rosuvastatin Versus Low-dose Rosuvastatin Plus Ezetimibe on Carotid Plaque Inflammation in Patients With Acute Coronary Syndrome
Official title: Comparison of High-dose Rosuvastatin Versus Low-dose Rosuvastatin Plus Ezetimibe on Carotid Plaque Inflammation in Patients With Acute Coronary Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Coronary Syndrome
Carotid Atherosclerotic Plaque With Inflammation
Keywords: rosuvastatin
ezetimibe/rosuvastatin
carotid plaque inflammation
fluorodeoxyglucose F18
positron emission tomography
Lead sponsor: Yuhan Corporation
Sponsor class: INDUSTRY
First posted: 2019-08-14
Enrollment: 50
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Percent change in most-diseased segment (MDS)-tissue blood ratio (TBR) of the index vessel
timeFrame: 6 months
Secondary outcomes:
measure: Change in MDS TBR
timeFrame: 6 months
measure: Change in whole vessel TBR within the index vessel
timeFrame: 6 months
measure: Change in whole vessel TBR of the aorta
timeFrame: 6 months
measure: Change in total cholesterol
timeFrame: 6 months
measure: Change in triglyceride
timeFrame: 6 months
measure: Change in HDL-cholesterol
timeFrame: 6 months
measure: Change in LDL-cholesterol
timeFrame: 6 months
measure: Change in high sensitive C-reactive protein
timeFrame: 6 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
Study officials:
References: