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Pleotropic Effect of New Oral Anticoagulants

Primary Purpose

Atrial Fibrillation

Status
Unknown status
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
dabigatran
ribaroxaban
Warfarin
Sponsored by
Kyunghee University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring anticoagulant, atherosclerosis, endothelium

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • CHA2DS2-VASc score above 2

Exclusion Criteria:

  • severe peripheral arterial disease (greater than a Fontaine IIb category)
  • grade 4 or higher cerebral infarction on the Modified Rankin Scale
  • proven coronary artery disease by coronary angiogram
  • severe hepatic or renal dysfunction
  • uncontrolled congestive heart failure
  • uncontrolled hypertension or diabetes mellitus
  • hematologic disorders
  • allergy or hypersensitivity to the investigational drugs
  • pregnant or lactating women or women wishing to become pregnant

Sites / Locations

  • Kyung Hee University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

dabigatran 110mg or 150mg

ribaroxaban 20mg

warfarin

Arm Description

After once enrolled, subjects will be randomized to dabigatran group. (110mg or 150mg twice a day)

After once enrolled, subjects will be randomized to ribaroxaban group. (20mg once daily)

After once enrolled, subjects will be randomized to warfarin group. (controlled by INR 2-3)

Outcomes

Primary Outcome Measures

The changes in reactive hyperemia index (RHI)

Secondary Outcome Measures

right and left maximum IMT of the common carotid artery (CCA)
right and left mean IMT of the common carotid artery (CCA)
adverse events

Full Information

First Posted
September 7, 2015
Last Updated
September 7, 2015
Sponsor
Kyunghee University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02544932
Brief Title
Pleotropic Effect of New Oral Anticoagulants
Official Title
Prospective Randomized Study for Evaluating Vascular Protective Effects of New Oral Anticoagulants in High Risk Patients With Atrial Fibrillation
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Unknown status
Study Start Date
October 2015 (undefined)
Primary Completion Date
September 2017 (Anticipated)
Study Completion Date
September 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kyunghee University Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Atrial fibrillation (AF) has been known to have several pathophysiologic mechanisms including endothelial dysfunction of heart and vessel. This study was designed to determine the efficacy of NOAC therapy in the prevention of endothelial dysfunction and progression of atherosclerosis of AF subjects.
Detailed Description
The properties of oral, direct inhibitors of factor Xa (e.g. rivaroxaban) and thrombin (e.g. dabigatran) have been examined the haemostasis and thromboembolism management. Preclinical studies have provided evidences for the effects of direct factor Xa or thrombin inhibition beyond anticoagulation, including anti-inflammatory and protective activities in atherosclerotic plaque development . Therefore, this study evaluates the protective effects of NAOC with the reactive hyperemia peripheral arterial tonometry (RH-PAT) measurements reflecting endothelial function by Endo-PAT2000 and intima-media thickness (IMT) of the carotid artery, which is used as a surrogate endpoint of atherosclerosis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
anticoagulant, atherosclerosis, endothelium

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
55 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
dabigatran 110mg or 150mg
Arm Type
Experimental
Arm Description
After once enrolled, subjects will be randomized to dabigatran group. (110mg or 150mg twice a day)
Arm Title
ribaroxaban 20mg
Arm Type
Experimental
Arm Description
After once enrolled, subjects will be randomized to ribaroxaban group. (20mg once daily)
Arm Title
warfarin
Arm Type
Active Comparator
Arm Description
After once enrolled, subjects will be randomized to warfarin group. (controlled by INR 2-3)
Intervention Type
Drug
Intervention Name(s)
dabigatran
Other Intervention Name(s)
pradaxa
Intervention Description
After randomization, patients of this group was will be treated to dabigatran 110mg or 150mg twice a day for 24months
Intervention Type
Drug
Intervention Name(s)
ribaroxaban
Other Intervention Name(s)
xarelto
Intervention Description
After randomization, patients of this group was will be treated to ribaroxaban 20mg once a day for 24months.
Intervention Type
Drug
Intervention Name(s)
Warfarin
Intervention Description
After randomization, patients of this group was will be treated to warfarin and controlled by INR 2-3 for 24months.
Primary Outcome Measure Information:
Title
The changes in reactive hyperemia index (RHI)
Time Frame
12months
Secondary Outcome Measure Information:
Title
right and left maximum IMT of the common carotid artery (CCA)
Time Frame
24months
Title
right and left mean IMT of the common carotid artery (CCA)
Time Frame
24months
Title
adverse events
Time Frame
24months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: CHA2DS2-VASc score above 2 Exclusion Criteria: severe peripheral arterial disease (greater than a Fontaine IIb category) grade 4 or higher cerebral infarction on the Modified Rankin Scale proven coronary artery disease by coronary angiogram severe hepatic or renal dysfunction uncontrolled congestive heart failure uncontrolled hypertension or diabetes mellitus hematologic disorders allergy or hypersensitivity to the investigational drugs pregnant or lactating women or women wishing to become pregnant
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Weon Kim, MD, PhD
Phone
82-2-958-8170
Email
mylovekw@hanmail.net
First Name & Middle Initial & Last Name or Official Title & Degree
Jin-Bae Kim, MD, PhD
Phone
82-2-958-8167
Email
jinbbai@khu.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Weon Kim, MD, PhD
Organizational Affiliation
Kyunghee University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kyung Hee University
City
Seoul
ZIP/Postal Code
130-702
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
27558002
Citation
Kim JB, Joung HJ, Lee JM, Woo JS, Kim WS, Kim KS, Lee KH, Kim W. Evaluation of the vascular protective effects of new oral anticoagulants in high-risk patients with atrial fibrillation (PREFER-AF): study protocol for a randomized controlled trial. Trials. 2016 Aug 24;17(1):422. doi: 10.1186/s13063-016-1541-8.
Results Reference
derived

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Pleotropic Effect of New Oral Anticoagulants

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