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EdoxabaN or Warfarin Therapy In Device Procedures in Patients With Non-Valvular Atrial Fibrillation (ENTICED-AF)

Primary Purpose

Atrial Fibrillation

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Edoxaban
Warfarin
Sponsored by
Electrophysiology Research Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

  • 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

Sites / Locations

  • Electrophysiology Research Foundation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Edoxaban

Warfarin

Arm Description

Edoxaban 30 or 60 mg

Warfarin 1 -1 0 mg

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 24, 2015
Last Updated
June 17, 2020
Sponsor
Electrophysiology Research Foundation
Collaborators
Axio Research Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT02561897
Brief Title
EdoxabaN or Warfarin Therapy In Device Procedures in Patients With Non-Valvular Atrial Fibrillation
Acronym
ENTICED-AF
Official Title
Efficacy and Safety of Edoxaban or Warfarin Therapy In Cardiovascular Implantable Electrical Device Procedures in Patients With Non-valvular Atrial Fibrillation
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Terminated
Why Stopped
Did not meet enrolment target for phase 1
Study Start Date
December 2015 (Actual)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Electrophysiology Research Foundation
Collaborators
Axio Research Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Edoxaban
Arm Type
Experimental
Arm Description
Edoxaban 30 or 60 mg
Arm Title
Warfarin
Arm Type
Active Comparator
Arm Description
Warfarin 1 -1 0 mg
Intervention Type
Drug
Intervention Name(s)
Edoxaban
Other Intervention Name(s)
Savaysa
Intervention Type
Drug
Intervention Name(s)
Warfarin
Primary Outcome Measure Information:
Title
Major Bleeding
Description
Major local or systemic bleeding as defined in the protocol at 30 days after implant procedure
Time Frame
Within 30 days of procedure
Secondary Outcome Measure Information:
Title
Thromboembolic and Cardiovascular Events
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sanjeev Saksena, MBBS MD
Organizational Affiliation
Electrophysiology Research Foundation
Official's Role
Study Chair
Facility Information:
Facility Name
Electrophysiology Research Foundation
City
Warren
State/Province
New Jersey
ZIP/Postal Code
07059
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.eprf.org
Description
Related Info

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

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