Comparison of Fimasartan Versus Amlodipine Therapy on Carotid PlaquE Inflammation

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effects of angiotensin receptor 1 blocker versus calcium channel blocker on atherosclerotic plaque inflammation using serial FDG PET/CT imaging of carotid artery.

Official Title
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Comparison of Fimasartan Versus Amlodipine Therapy on Carotid PlaquE Inflammation

Conditions
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Inflammation Plaque, Atherosclerotic, Coronary Disease, Renin-Angiotensin System

Intervention / Treatment
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* Drug: 6-month treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men or Women at least 18 years of age inclusive Patients with acute coronary syndromes or unstable angina pectoris Hypertension or blood pressure more than 140/90mmHg FDG PET/CT shows at least 1 hot uptakes at carotid and or ascending aorta The patient or guardian agrees to the study protocol and the schedule of clinical and FDG PET/CT follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site. Exclusion Criteria: Patients treated with carotid endarterectomy or stent placement Chronic disease requiring treatment with oral, intravenous, or intra-articular corticosteroids (use of topical, inhaled, or nasal corticosteroids is permissible). Untreated hyperthyroidism, or hypothyroidism Any clinically significant abnormality identified at the screening visit, physical examination, laboratory tests, or electrocardiogram which, in the judgment of the Investigator, would preclude safe completion of the study. Evidence of congestive heart failure, or left ventricular ejection fraction < 40%. Significant renal disease manifested by serum creatinine > 2.0mg/dL, or creatinine clearance of < 40 ml/min (by Cockcroft-Gault method). Hepatic disease or biliary tract obstruction, or significant hepatic enzyme elevation (ALT or AST > 3 times upper limit of normal). History of adult asthma manifested by bronchospasm in the past 6 months, or currently taking regular anti-asthmatic medication(s). Unwillingness or inability to comply with the procedures described in this protocol. Patient's pregnant or breast-feeding or child-bearing potential. Type I Diabetes

Ages Eligible for Study
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Minimum Age: 18 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: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fimasartan and vytorin<br>fimasartan(60mg,QD)+Vytorin(10mg,QD) | Drug: 6-month treatment<br> <br> |
| Experimental: Fimasartan and rosuvastatin<br>fimasartan(60mg,QD)+rosuvastatin(5mg,QD) | Drug: 6-month treatment<br> <br> |
| Active Comparator: amlodipine and vytorin<br>amlodipine(5mg,QD)+Vytorin(10mg,QD) | Drug: 6-month treatment<br> <br> |
| Active Comparator: amlodipine and rosuvastatin<br>amlodipine(5mg,QD+rosuvastatin(5mg,QD) | Drug: 6-month treatment<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change (follow-up minus baseline) in standardized FDG uptake value | change (follow-up minus baseline) in standardized FDG uptake value within the regions of interest, known as a target-to-background ratio (blood-normalized standardized uptake value). | 6month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes of blood pressure | systolic and diastolic | 6month | 
| Serial changes of lipid battery | total cholesterol, triglyceride, HDL-cholesterol, LDL-cholesterol | 6month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fluorodeoxyglucose F18, Positron-Emission Tomography and Computed Tomography, Plaque, Atherosclerotic, Renin-Angiotensin System