NCT02544932

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
55

participants targeted

Target at below P25 for phase_3 atrial-fibrillation

Timeline
Completed

Started Oct 2015

Shorter than P25 for phase_3 atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 7, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 9, 2015

Completed
22 days until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

September 9, 2015

Status Verified

September 1, 2015

Enrollment Period

1.9 years

First QC Date

September 7, 2015

Last Update Submit

September 7, 2015

Conditions

Atrial Fibrillation

Keywords

anticoagulantatherosclerosisendothelium

Outcome Measures

Primary Outcomes (1)

  • The changes in reactive hyperemia index (RHI)

    12months

Secondary Outcomes (3)

  • right and left maximum IMT of the common carotid artery (CCA)

    24months

  • right and left mean IMT of the common carotid artery (CCA)

    24months

  • adverse events

    24months

Study Arms (3)

dabigatran 110mg or 150mg

EXPERIMENTAL

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

Drug: dabigatran

ribaroxaban 20mg

EXPERIMENTAL

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

Drug: ribaroxaban

warfarin

ACTIVE COMPARATOR

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

Drug: Warfarin

Interventions

dabigatranDRUG

After randomization, patients of this group was will be treated to dabigatran 110mg or 150mg twice a day for 24months

Also known as: pradaxa
dabigatran 110mg or 150mg
ribaroxabanDRUG

After randomization, patients of this group was will be treated to ribaroxaban 20mg once a day for 24months.

Also known as: xarelto
ribaroxaban 20mg
WarfarinDRUG

After randomization, patients of this group was will be treated to warfarin and controlled by INR 2-3 for 24months.

warfarin

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • CHA2DS2-VASc score above 2

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kyung Hee University

Seoul, 130-702, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 27558002DERIVED

MeSH Terms

Conditions

Atrial FibrillationAtherosclerosis

Interventions

DabigatranRivaroxabanWarfarin

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

PyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingThiophenesSulfur CompoundsOrganic ChemicalsMorpholinesOxazines4-HydroxycoumarinsCoumarinsBenzopyransPyrans

Study Officials

  • Weon Kim, MD, PhD

    Kyunghee University Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Weon Kim, MD, PhD

CONTACT

82-2-958-8170mylovekw@hanmail.net

Jin-Bae Kim, MD, PhD

CONTACT

82-2-958-8167jinbbai@khu.ac.kr

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

September 7, 2015

First Posted

September 9, 2015

Study Start

October 1, 2015

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

September 9, 2015

Record last verified: 2015-09

Locations

KR(1)