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

Study Overview
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Brief Summary
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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.

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

Conditions
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Acute Coronary Syndrome, Carotid Atherosclerotic Plaque With Inflammation

Intervention / Treatment
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* Drug: high-dose rosuvastatin
* Drug: low-dose rosuvastatin plus ezetimibe


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged ≥ 19 years 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 written consent Exclusion Criteria: previous history of carotid endarterectomy or stenting schedule for cardiac or major surgery within the next 6 months statin or ezetimibe therapy in the past 4 weeks chronic disease needed to be treated with oral, intravenous, or intraarticular steroid end-stage renal disease chronic liver disease history of cancers within the past 3 years pregnant, breast-feeding or child-bearing potential expected life expectancy within 2 years

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Rosuvastatin<br>rosuvastatin 20 mg once a day for 6 months | Drug: high-dose rosuvastatin<br>* rosuvastatin 20 mg once a day for 6 months<br>|
| Experimental: ezetimibe/rosuvastatin<br>ezetimibe/rosuvastatin 10/5 mg once a day for 6 months | Drug: low-dose rosuvastatin plus ezetimibe<br>* ezetimibe/rosuvastatin 10/5 mg once a day for 6 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change in most-diseased segment (MDS)-tissue blood ratio (TBR) of the index vessel |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rosuvastatin, ezetimibe/rosuvastatin, carotid plaque inflammation, fluorodeoxyglucose F18, positron emission tomography