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

Yuhan Corporation50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acute Coronary Syndrome Carotid Atherosclerotic Plaque With Inflammation

Interventions

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Percent change in most-diseased segment (MDS)-tissue blood ratio (TBR) of the index vessel

Time frame: 6 months

Secondary Outcomes

Change in MDS TBR

Time frame: 6 months

Change in whole vessel TBR within the index vessel

Time frame: 6 months

Change in whole vessel TBR of the aorta

Time frame: 6 months

Change in total cholesterol

Time frame: 6 months

Change in triglyceride

Time frame: 6 months

Change in HDL-cholesterol

Time frame: 6 months

Change in LDL-cholesterol

Time frame: 6 months

Change in high sensitive C-reactive protein

Time frame: 6 months

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

Overview

Conditions

Interventions

Eligibility

Locations (2)

Outcomes

Primary Outcomes

Secondary Outcomes