FACE: Comparison of Fimasartan Versus Amlodipine Therapy on Carotid PlaquE Inflammation

Sponsor

CHEOL WHAN LEE, M.D., Ph.D (Other)

Overall Status

Completed

CT.gov ID

NCT02378064

Collaborator

Boryung Pharmaceutical Co., Ltd (Industry)

Enrollment

Location

Arms

Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Inflammation Plaque, Atherosclerotic Coronary Disease Renin-Angiotensin System	Drug: 6-month treatment	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Comparison of Fimasartan Versus Amlodipine Therapy on Carotid PlaquE Inflammation

Study Start Date :

May 1, 2015

Actual Primary Completion Date :

Dec 1, 2017

Actual Study Completion Date :

Dec 1, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

change (follow-up minus baseline) in standardized FDG uptake value [6month]
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).

Secondary Outcome Measures

changes of blood pressure [6month]
systolic and diastolic
Serial changes of lipid battery [6month]
total cholesterol, triglyceride, HDL-cholesterol, LDL-cholesterol

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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