Comparison of Fimasartan Versus Amlodipine Therapy on Carotid PlaquE Inflammation

NCT02378064 | Completed Phase 4 DMC

• 1 other identifier: AMCCV2014-10
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• changes of blood pressure

  6month

• Serial changes of lipid battery

  6month

Study Arms (4)

Fimasartan and vytorin

EXPERIMENTAL

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

Drug: 6-month treatment

Fimasartan and rosuvastatin

EXPERIMENTAL

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

Drug: 6-month treatment

amlodipine and vytorin

ACTIVE COMPARATOR

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

Drug: 6-month treatment

amlodipine and rosuvastatin

ACTIVE COMPARATOR

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

Drug: 6-month treatment

Interventions

6-month treatment DRUG

Fimasartan and rosuvastatin; Fimasartan and vytorin; amlodipine and rosuvastatin; amlodipine and vytorin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• CHEOL WHAN LEE, M.D., Ph.D: lead
• Boryung Pharmaceutical Co., Ltd: collaborator

Study Sites (1)

Asan Medical Center

Seoul, South Korea

Location

Related Publications (1)

• 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.

  PMID: 31426749 DERIVED

MeSH Terms

Conditions

Coronary Disease; Plaque, Atherosclerotic

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: February 26, 2015
• First Posted: March 4, 2015
• Study Start: May 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: January 5, 2018

Record last verified: 2018-01

Locations

KR (1)