Comparison of Fimasartan Versus Amlodipine Therapy on Carotid PlaquE Inflammation

Phase 4

Completed

• Conditions: Renin-Angiotensin System; Coronary Disease; Inflammation Plaque, Atherosclerotic
• Interventions: Drug: 6-month treatment

• Registration Number: NCT02378064
• Lead Sponsor: CHEOL WHAN LEE, M.D., Ph.D

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-02-26
• Study First Submitted QC: 2015-02-26
• Study First Posted: 2015-03-04
• Study Start: 2015-05
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-04
• Last Update Posted: 2018-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Fimasartan and rosuvastatin	6-month treatment	fimasartan(60mg,QD)+rosuvastatin(5mg,QD)
amlodipine and vytorin	6-month treatment	amlodipine(5mg,QD)+Vytorin(10mg,QD)
amlodipine and rosuvastatin	6-month treatment	amlodipine(5mg,QD+rosuvastatin(5mg,QD)
Fimasartan and vytorin	6-month treatment	fimasartan(60mg,QD)+Vytorin(10mg,QD)

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
changes of blood pressure	6month	systolic and diastolic
Serial changes of lipid battery	6month	total cholesterol, triglyceride, HDL-cholesterol, LDL-cholesterol

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of