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

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

Status and phase: Completed; Phase 4

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

Treatments: Drug: 6-month treatment

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02378064

AMCCV2014-10

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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50 participants in 4 patient groups

Fimasartan and vytorin

Experimental group

Description:

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

Treatment:

Drug: 6-month treatment

Fimasartan and rosuvastatin

Experimental group

Description:

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

Treatment:

Drug: 6-month treatment

amlodipine and vytorin

Active Comparator group

Description:

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

Treatment:

Drug: 6-month treatment

amlodipine and rosuvastatin

Active Comparator group

Description:

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

Treatment:

Drug: 6-month treatment