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Comparison of Fimasartan Versus Amlodipine Therapy on Carotid PlaquE Inflammation (FACE)

Primary Purpose

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

Status

Completed

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

6-month treatment

About this trial

This is an interventional treatment trial for Inflammation Plaque, Atherosclerotic focused on measuring Fluorodeoxyglucose F18, Positron-Emission Tomography and Computed Tomography, Plaque, Atherosclerotic, Renin-Angiotensin System

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Asan Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Arm Label

Fimasartan and vytorin

Fimasartan and rosuvastatin

amlodipine and vytorin

amlodipine and rosuvastatin

Arm Description

fimasartan(60mg,QD)+Vytorin(10mg,QD)

fimasartan(60mg,QD)+rosuvastatin(5mg,QD)

amlodipine(5mg,QD)+Vytorin(10mg,QD)

amlodipine(5mg,QD+rosuvastatin(5mg,QD)

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

changes of blood pressure

systolic and diastolic

Serial changes of lipid battery

total cholesterol, triglyceride, HDL-cholesterol, LDL-cholesterol

Full Information

NCT ID

NCT02378064

First Posted

February 26, 2015

Last Updated

January 4, 2018

Sponsor

CHEOL WHAN LEE, M.D., Ph.D

Collaborators

Boryung Pharmaceutical Co., Ltd

1. Study Identification

Unique Protocol Identification Number

NCT02378064

Brief Title

Comparison of Fimasartan Versus Amlodipine Therapy on Carotid PlaquE Inflammation

Acronym

FACE

Official Title

Comparison of Fimasartan Versus Amlodipine Therapy on Carotid PlaquE Inflammation

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Completed

Study Start Date

May 2015 (undefined)

Primary Completion Date

December 2017 (Actual)

Study Completion Date

December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

CHEOL WHAN LEE, M.D., Ph.D

Collaborators

Boryung Pharmaceutical Co., Ltd

4. Oversight

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Fluorodeoxyglucose F18, Positron-Emission Tomography and Computed Tomography, Plaque, Atherosclerotic, Renin-Angiotensin System

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Factorial Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Fimasartan and vytorin

Arm Type

Experimental

Arm Description

fimasartan(60mg,QD)+Vytorin(10mg,QD)

Arm Title

Fimasartan and rosuvastatin

Arm Type

Experimental

Arm Description

fimasartan(60mg,QD)+rosuvastatin(5mg,QD)

Arm Title

amlodipine and vytorin

Arm Type

Active Comparator

Arm Description

amlodipine(5mg,QD)+Vytorin(10mg,QD)

Arm Title

amlodipine and rosuvastatin

Arm Type

Active Comparator

Arm Description

amlodipine(5mg,QD+rosuvastatin(5mg,QD)

Intervention Type

Drug

Intervention Name(s)

6-month treatment

Primary Outcome Measure Information:

Title

change (follow-up minus baseline) in standardized FDG uptake value

Description

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).

Time Frame

6month

Secondary Outcome Measure Information:

Title

changes of blood pressure

Description

systolic and diastolic

Time Frame

6month

Title

Serial changes of lipid battery

Description

total cholesterol, triglyceride, HDL-cholesterol, LDL-cholesterol

Time Frame

6month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Asan Medical Center

City

Seoul

Country

Korea, Republic of

12. IPD Sharing Statement

Citations:

PubMed Identifier

31426749

Citation

Oh M, Kim H, Shin EW, Sung C, Kim DH, Moon DH, Lee CW. Effects of ezetimibe/simvastatin 10/10 mg versus Rosuvastatin 10 mg on carotid atherosclerotic plaque inflammation. BMC Cardiovasc Disord. 2019 Aug 19;19(1):201. doi: 10.1186/s12872-019-1184-2.

Results Reference

derived

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Comparison of Fimasartan Versus Amlodipine Therapy on Carotid PlaquE Inflammation

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