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  • Status : Approved
    • First Submitted Date : 2019/06/24
    • Registered Date : 2019/07/11
    • Last Updated Date : 2019/07/10
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1. Background

Background Information
CRIS
Registration Number
KCT0004133 
Unique Protocol ID HALLYM 2019-04-032-001 
Public/Brief Title RandomizEd comparison of PRogrESsion of atherosclerotic plaquEs aNd calcification of coronary artery in Atrial Fibrillation Patients treated with edoxaban versus warfarin (The REPRESENT-AF trial). 
Scientific Title RandomizEd comparison of PRogrESsion of atherosclerotic plaquEs aNd calcification of coronary artery in Atrial Fibrillation Patients treated with edoxaban versus warfarin (The REPRESENT-AF trial).  
Acronym  
MFDS Regulated Study No
IND/IDE Protocol No
Registered
at Other Registry
No
Healthcare Benefit
Approval Status
Submitted pending

2. Institutional Review Board/Ethics Committee

Institutional Review Board Information
Board Approval Status Submitted approval 
Board Approval Number HALLYM 2019-04-032-001 
Approval Date 2019-06-04 
Institutional Review Board  
Name Hallym University Sacred Heart Hospital Clinical Trial Review Committee/ Institutional Bioethics Committee HUSHIRB 
Address 22, Gwanpyeong-ro 170beon-gil, Dongan-gu, Anyang-si, Gyeonggi-do 
Telephone 02-380-1975 
Data Monitoring Committee Yes
Hallym University Sacred Heart Hospital Monitoring Committee    

3. Contact Details

Contact Details Information
Contact Person for Principal Investigator / Scientific Queries  
Name Hong Euy Lim 
Title Professor 
Telephone +82-31-380-3889 
Affiliation Hallym University Medical Center 
Address 22, Gwanpyeong-ro 170beon-gil, Dongan-gu, Anyang-si, Gyeonggi-do 
Contact Person for Public Queries
Name Hong Euy Lim 
Title Professor 
Telephone +82-31-380-3889 
Affiliation Hallym University Medical Center 
Address 22, Gwanpyeong-ro 170beon-gil, Dongan-gu, Anyang-si, Gyeonggi-do 
Contact Person for Updating Information
Name Hong Euy Lim 
Title Professor 
Telephone +82-31-380-3889 
Affiliation Hallym University Medical Center 
Address 22, Gwanpyeong-ro 170beon-gil, Dongan-gu, Anyang-si, Gyeonggi-do 

4. Status

Status Information
Study Site Multi-center (Number of center : 8)
Overall Recruitment Status Not yet recruiting  
Date of First Enrollment 2019-08-01 , Anticipated
Target Number of Participant 150
Primary Completion Date 2024-07-31 , Anticipated
Study Completion Date 2024-07-31 , Anticipated
Recruitment Status by Participating Study Site 1
Name of Study Site Seoul National University Hospital 
Recruitment Status Not yet recruiting  
Date of First Enrollment 2019-08-01 , Anticipated
Recruitment Status by Participating Study Site 2
Name of Study Site Seoul National University Bundang Hospital 
Recruitment Status Not yet recruiting  
Date of First Enrollment 2019-08-01 , Anticipated
Recruitment Status by Participating Study Site 3
Name of Study Site Samsung Medical Center 
Recruitment Status Not yet recruiting  
Date of First Enrollment 2019-08-01 , Anticipated
Recruitment Status by Participating Study Site 4
Name of Study Site Korea University Anam Hospital 
Recruitment Status Not yet recruiting  
Date of First Enrollment 2019-08-01 , Anticipated
Recruitment Status by Participating Study Site 5
Name of Study Site Chung-Ang Univerisity Hospital 
Recruitment Status Not yet recruiting  
Date of First Enrollment 2019-08-01 , Anticipated
Recruitment Status by Participating Study Site 6
Name of Study Site Pusan National University Hospital 
Recruitment Status Not yet recruiting  
Date of First Enrollment 2019-08-01 , Anticipated
Recruitment Status by Participating Study Site 7
Name of Study Site Hallym University Medical Center-Kangnam 
Recruitment Status Not yet recruiting  
Date of First Enrollment 2019-08-01 , Anticipated
Recruitment Status by Participating Study Site 8
Name of Study Site Hallym University Medical Center-Dongtan 
Recruitment Status Not yet recruiting  
Date of First Enrollment 2019-08-01 , Anticipated

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information
Source of Monetary/Material Support 1   
Organization Name Daiichi-Sankyo Korea 
Organization Type Pharmaceutical Company  
Project ID  

6. Sponsor Organization

Sponsor Organization Information
Sponsor Organization 1   
Organization Name Hallym University Medical Center 
Organization Type Medical Institute  

7. Study Summary

Study Summary Information
Lay Summary Patients with atrial fibrillation take anticoagulant according to CHA2DS2-VASc scores to prevent stroke and other embolism. The frequency of arteriosclerosis disease accompanying patients in atrial fibrillation is known to be very common. Vitamin K antagonists (VKAs) are known to increase vascular calcification, suggesting increased cardiovascular disease events. Edoxaban is an oral direct factor Xa inhibitor superior to warfarin at preventing stroke or systemic embolism and may stabilize coronary atherosclerosis. The potential benefits of avoiding VKA therapy and the favorable effects of factor Xa inhibitors could contribute to cardiovascular disease event reduction. We hypothesized that edoxan inhibits vascular calcification and coronary atherosclerosis progression compared with warfarin in patients with atrial fibrillation (AF). This study is a multicenter, prospective, randomized, open-label study. Patients were randomized into either warfarin or exdoxan group and followed for 1 year. The primary efficacy endpoint is analyzed coronary artery computer tomography result to assess changes in volume and character of the plaque of coronary arteries and changes in the calcium core. The primary safety endpoint is Incidence of major bleeding related to oral anticoagulant according to International Society of Thrombosis and Hemostasis criteria(decrease in hemoglobin level of at least 2g/dl or at least 2 pack RBC transfusion, or intracranial, intraocular, intrathecal, pericardial, retroperitoneal, intra-articular or muscular bleeding causing compartment syndrome). The secondary objective is major cardiovascular events, cardiovascular mortality, mortality from all causes, time in therapeutic range of warfarin using Rosendall method (Warfarin treatment group only), anticoagulants discontinuation rate.  

8. Study Design

Study Design Information
Study Type Observational Study 
Observational Study Model Case-control 
Time Perspective Prospective    
Target Number of Participant 150
Cohort/Group Number
Cohort/
Group 1
Cohort/Group
Label
Edoxaban group 
Cohort/Group
Description
Edoxaban 60 mg taken once a day (30 mg taken once a day if 15< Creatinine clearance<50 ml/min, Weigth ≤ 60 kg or take a medicine-ex. p-glycoprotein inhibitor :verapamil, quinidine, dronedarone, cyclosporine, erythromycin, ketoconazole, etc) Check bleeding complications and side effects of Edoxaban 
Biospecimen
Collection & Archiving
Not collect nor Archive 
Biospecimen Description  
Cohort/
Group 2
Cohort/Group
Label
Warfarin group 
Cohort/Group
Description
check INR and adjust dose with a goal of 2.0-3.0. check bleeding complications and side effects of warfarin 
Biospecimen
Collection & Archiving
Not collect nor Archive 
Biospecimen Description  

9. Subject Eligibility

Subject Eligibility Information
Study Population Description Patients were randomized into either warfarin or exdoxan group and followed for 1 year.  
Sampling Method Random assignment is made using random number tables made by stratified block random assignment method before anticoagulant administration.  
Condition(s)/Problem(s) * Diseases of the circulatory system
Rare Disease No
Inclusion
Criteria
Gender Both 
Age 19 Year ~ No Limit
Description 1.NVAF with CHA2DS2-VASc score ≥1
2.Coronary artery disease
the coronary artery is observed to have at least 20% arteriosclerotic stenosis in Coronary computed tomography angiography
3.Patients who have not previously taken oral anticoagulants
4.Age greater than or equal to 19 years
5.Willing and able to provide informed consent  
Exclusion Criteria 1.Unstable angina
2.Patients who have undergone a coronary stent procedure within the previous 12 months
3.Patients who have diagnosed with stroke within the previous 3 months
4.Moderate to severe mitral stenosis
5.Hypertrophic cardiomyopathy
6.Renal insufficiency (calculated CrCl <30 mL/min)
7.Patients who cannot take oral anticoagulants
8.Platelet count of <100 000/mm3 or Hgb <10 g/dL
9.GI bleeding event in the previous 6 months
10.Pregnancy  
Healthy Volunteers  

10. Outcome Measure(s)

Outcome Measure(s) Information
Type of Primary Outcome /Safety/Efficacy 
Primary Outcome(s) 1 
Outcome changes in volume and character of the plaque of coronary arteries 
Timepoint A year after administering anticoagulant medication 
Primary Outcome(s) 2 
Outcome Incidence of major bleeding 
Timepoint any symptoms or every visit at hosipital 
Secondary Outcome(s) 1 
Outcome major cardiovascular events 
Timepoint any symptoms or every visit at hosipital 

11. Study Results and Publication

Study Results and Publication Information
Result Registerd No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information
Sharing Statement Undecided 
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