Pleotropic Effect of New Oral Anticoagulants

September 7, 2015 updated by: Weon Kim, Kyunghee University Medical Center

Prospective Randomized Study for Evaluating Vascular Protective Effects of New Oral Anticoagulants in High Risk Patients With Atrial Fibrillation

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

55

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: dabigatran 110mg or 150mg
After once enrolled, subjects will be randomized to dabigatran group. (110mg or 150mg twice a day)
Drug: dabigatran
After randomization, patients of this group was will be treated to dabigatran 110mg or 150mg twice a day for 24months
Other Names:
  • pradaxa
Experimental: ribaroxaban 20mg
After once enrolled, subjects will be randomized to ribaroxaban group. (20mg once daily)
Drug: ribaroxaban
After randomization, patients of this group was will be treated to ribaroxaban 20mg once a day for 24months.
Other Names:
  • xarelto
Active Comparator: warfarin
After once enrolled, subjects will be randomized to warfarin group. (controlled by INR 2-3)
Drug: Warfarin
After randomization, patients of this group was will be treated to warfarin and controlled by INR 2-3 for 24months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The changes in reactive hyperemia index (RHI)
Time Frame: 12months
12months

Secondary Outcome Measures

Outcome Measure
Time Frame
right and left maximum IMT of the common carotid artery (CCA)
Time Frame: 24months
24months
right and left mean IMT of the common carotid artery (CCA)
Time Frame: 24months
24months
adverse events
Time Frame: 24months
24months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyunghee University Medical Center

Investigators

  • Principal Investigator: Weon Kim, MD, PhD, KyungHee University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Anticipated)

September 1, 2017

Study Completion (Anticipated)

September 1, 2017

Study Registration Dates

First Submitted

September 7, 2015

First Submitted That Met QC Criteria

September 7, 2015

First Posted (Estimate)

September 9, 2015

Study Record Updates

Last Update Posted (Estimate)

September 9, 2015

Last Update Submitted That Met QC Criteria

September 7, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PREFER-AF

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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