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TerminatedNCT02561897ENTICED-AFUpdated Jun 30, 2020Results posted

EdoxabaN or Warfarin Therapy In Device Procedures in Patients With Non-Valvular Atrial Fibrillation

A Phase 4 interventional study of Edoxaban and Warfarin in Atrial Fibrillation, sponsored by Electrophysiology Research Foundation. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-06-30.

Sponsored by Electrophysiology Research Foundation · Phase 4, Interventional, and Treatment

Why this study was terminated
Did not meet enrolment target for phase 1
Phase
Phase 4
Study type
Interventional
Enrollment
5
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This is a prospective randomized comparative evaluation of Edoxaban and Warfarin for safety and efficacy in perioperative use in patients with non-valvular atrial fibrillation (AF) undergoing clinically indicated implantation or replacement of cardiovascular implantable electrical devices.The primary objective is to compare the rates of local and systemic bleeding in subjects randomized to Edoxaban compared to subjects randomized to continuous warfarin in within 30 days of cardiac rhythm device implant with concomitant non-valvular AF.

Read the detailed description

This is a prospective randomized comparative evaluation of Edoxaban and Warfarin for safety and efficacy in perioperative use in patients with non-valvular atrial fibrillation undergoing clinically indicated implantation or replacement of cardiovascular implantable electrical devices. This study is a randomized, open label, active-controlled trial with an open-label safety extension, designed to compare local and systemic bleeding within 30 days of cardiac rhythm device implant among subjects randomized to continuous Warfarin or interrupted (\<24 hours) Edoxaban. The study will have three phases, a run in phase to establish stable warfarin therapy, an acute open label 30 day phase when subjects will be randomized in a 1:1 ratio to receive interrupted edoxaban or continuous warfarin followed by an open label follow up phase for an additional 5 months for safety monitoring. Drug transitions will be performed according to approved drug labeling.

02

Conditions studied

  • Atrial Fibrillation

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03

In context

Atrial Fibrillation

3,870 studies on the registry are indexed under Atrial Fibrillation; 923 are open to participants now.

This study's enrollment of 5 is below the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

Electrophysiology Research Foundation is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Subjects with established atrial fibrillation (AF) and bradycardia on long term (>3 weeks) therapeutic oral anticoagulant (OAC) with warfarin or another OAC who are undergoing new pacemaker system implant or existing pacemaker system revision.
  • Subjects with newly detected bradycardia -tachycardia syndrome and AF who have been recently (less than 3 weeks) started on warfarin, have a therapeutic international normalized ratio (INR) and no thrombus on trans-esophageal echocardiogram (TEE) who are undergoing a new pacemaker system implant or revision.
  • Subjects with AF and ventricular tachyarrhythmias (VT or VF) or acquired structural heart disease who are candidates for implantable cardioverter-defibrillator (ICD) therapy and are on long term (>3 weeks) therapeutic OAC with warfarin or another OAC who are undergoing new ICD system implant or existing ICD system revision.
  • Subjects with newly detected AF with VT or VF who have been recently (less than 3 weeks) started on warfarin, have a therapeutic INR and no thrombus on TEE who are undergoing ICD system implant or revision

Exclusion criteria

Exclusion Criteria:

  • Clinically significant valvular heart disease
  • Subjects requiring cardiovascular implantable electrical device (CIED) lead extraction e.g. for device site infection, endocarditis, leads under advisory or other conditions warranting lead(s) system extraction.
  • Recent (\<1 month) myocardial infarction
  • Documented left atrial (LA) thrombus on TEE
  • Contraindications to anticoagulant therapy or adverse event with prior warfarin or edoxaban therapy
  • Creatinine clearance \<30ml/min or >95 ml/min
  • Hepatic disease, advanced
  • Recent stroke (\<3 months) or thromboembolic event
  • Recent (\<3months) intracranial or other major bleeding event
  • Use of concomitant dual antiplatelet therapy or other oral, subcutaneous or parenteral anticoagulant therapy
  • Subjects on warfarin without therapeutic INR levels before study entry
  • Subjects with other clinically significant medical condition
  • Subjects with life expectancy \< 1 year
  • Lead extraction procedures
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
5 participants (actual)

Study arms

  • Experimental
    Edoxaban

    Edoxaban 30 or 60 mg

    Drug: Edoxaban

  • Active comparator
    Warfarin

    Warfarin 1 -1 0 mg

    Drug: Warfarin

Interventions

  • DrugEdoxaban

    Also known as: Savaysa

  • DrugWarfarin
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What researchers measure

Primary outcomes

  1. Major Bleeding

    Major local or systemic bleeding as defined in the protocol at 30 days after implant procedure

    Time frame: Within 30 days of procedure

Secondary outcomes

  1. Thromboembolic and Cardiovascular Events

    Thrombotic events (embolism or stroke) through 6 months following the procedure in the Edoxaban and Warfarin groups and the rates of MACE events through 6 months following the procedure in the Edoxaban and Warfarin groups

    Time frame: Within 6 months of procedure

07

Results

Posted Feb 10, 2020

Participant flow

Recruitment period 2015-2017 Recruited in hospital and medical clinic

Participant flow — Overall Study
MilestoneEdoxabanWarfarin
Started23
Completed23
Not completed00

Outcome measures

PrimaryMajor Bleeding

Major local or systemic bleeding as defined in the protocol at 30 days after implant procedure

Time frame:
Within 30 days of procedure
Reported as:
Count of participants · Participants
Major Bleeding
ParticipantsWarfarinEdoxaban
Major Bleeding10
SecondaryThromboembolic and Cardiovascular Events

Thrombotic events (embolism or stroke) through 6 months following the procedure in the Edoxaban and Warfarin groups and the rates of MACE events through 6 months following the procedure in the Edoxaban and Warfarin groups

Time frame:
Within 6 months of procedure
Reported as:
Count of participants · Participants
Thromboembolic and Cardiovascular Events
ParticipantsWarfarinEdoxaban
Thromboembolic and Cardiovascular Events00

Adverse events

Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Warfarin0/3 (0%)2/3 (66.7%)0/3 (0%)
Edoxaban0/2 (0%)0/2 (0%)0/2 (0%)
Most frequent serious events
Most frequent serious events
EventWarfarinEdoxaban
HematomaInjury, poisoning and procedural complications1/30/2
Superficial wound infectionSkin and subcutaneous tissue disorders1/30/2

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)EdoxabanWarfarinTotal
<=18 years000
Between 18 and 65 years112
>=65 years123
Age, Continuous
Age, Continuous(years)EdoxabanWarfarinTotal
Mean60.5 ± 13.472.0 ± 12.569.4 ± 13
Sex: Female, Male
Sex: Female, Male(Participants)EdoxabanWarfarinTotal
Female011
Male224
Race (NIH/OMB)
Race (NIH/OMB)(Participants)EdoxabanWarfarinTotal
American Indian or Alaska Native000
Asian000
Native Hawaiian or Other Pacific Islander000
Black or African American000
White235
More than one race000
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(Participants)EdoxabanWarfarinTotal
United States235
08

Study locations

1 site
  • Electrophysiology Research Foundation
    Warren, New Jersey 07059, United States
09

References and documents

Related links

Study documents

  • Protocol and statistical analysis plan · Dec 24, 2015

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 30, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02561897
Lead sponsor
Electrophysiology Research Foundation
Collaborators
Axio Research Corporation
Responsible party
Sponsor
First posted
Sep 28, 2015
Start date
Dec 2015
Primary completion
Sep 2017
Completion
Dec 2017
Results posted
Feb 10, 2020
Last update
Jun 30, 2020

Study contacts

Sanjeev Saksena, MBBS MD
study chair · Electrophysiology Research Foundation

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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