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OpenTrials
Completed

NCT Number: NCT02378064

Comparison of Fimasartan Versus Amlodipine Therapy on Carotid PlaquE Inflammation

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Asan Medical Center

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

6-month treatment

Drug

Primary outcomes

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

    Time frame: 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 outcomes

  1. changes of blood pressure

    Time frame: 6month

    systolic and diastolic

  2. Serial changes of lipid battery

    Time frame: 6month

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

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Boryung Pharmaceutical Co., Ltd

Registry information

Acronym: FACE

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Mar 4, 2015
Registry last updated
Jan 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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