Comparison of Fimasartan Versus Amlodipine Therapy on Carotid PlaquE Inflammation

Coronary Disease Clinical Trial

— FACE  

Official title:

Comparison of Fimasartan Versus Amlodipine Therapy on Carotid PlaquE Inflammation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02378064
• Other study ID #: AMCCV2014-10
• Status: Completed
• Phase: Phase 4
• First received: February 26, 2015
• Last updated: January 4, 2018
• Start date: May 2015
• Est. completion date: December 2017

Study information

• Verified date: January 2018
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• 6-month treatment

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
CHEOL WHAN LEE, M.D., Ph.D	Boryung Pharmaceutical Co., Ltd

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	changes of blood pressure	systolic and diastolic	6month
Secondary	Serial changes of lipid battery	total cholesterol, triglyceride, HDL-cholesterol, LDL-cholesterol	6month