Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02561897
Recruitment Status : Terminated (Did not meet enrolment target for phase 1)
First Posted : September 28, 2015
Results First Posted : February 10, 2020
Last Update Posted : June 30, 2020
Sponsor:
Collaborator:
Axio Research Corporation
Information provided by (Responsible Party):
Electrophysiology Research Foundation

Tracking Information
First Submitted Date  ICMJE September 24, 2015
First Posted Date  ICMJE September 28, 2015
Results First Submitted Date  ICMJE January 28, 2020
Results First Posted Date  ICMJE February 10, 2020
Last Update Posted Date June 30, 2020
Actual Study Start Date  ICMJE December 2015
Actual Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 25, 2015)
Major Bleeding [ Time Frame: Within 30 days of procedure ]
Major local or systemic bleeding as defined in the protocol at 30 days after implant procedure
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 25, 2015)
Thromboembolic and Cardiovascular Events [ Time Frame: Within 6 months of procedure ]
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE EdoxabaN or Warfarin Therapy In Device Procedures in Patients With Non-Valvular Atrial Fibrillation
Official Title  ICMJE Efficacy and Safety of Edoxaban or Warfarin Therapy In Cardiovascular Implantable Electrical Device Procedures in Patients With Non-valvular Atrial Fibrillation
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Atrial Fibrillation
Intervention  ICMJE
  • Drug: Edoxaban
    Other Name: Savaysa
  • Drug: Warfarin
Study Arms  ICMJE
  • Experimental: Edoxaban
    Edoxaban 30 or 60 mg
    Intervention: Drug: Edoxaban
  • Active Comparator: Warfarin
    Warfarin 1 -1 0 mg
    Intervention: Drug: Warfarin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 8, 2017)
5
Original Estimated Enrollment  ICMJE
 (submitted: September 25, 2015)
400
Actual Study Completion Date  ICMJE December 2017
Actual Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02561897
Other Study ID Numbers  ICMJE EPRF2015-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Electrophysiology Research Foundation
Study Sponsor  ICMJE Electrophysiology Research Foundation
Collaborators  ICMJE Axio Research Corporation
Investigators  ICMJE
Study Chair: Sanjeev Saksena, MBBS MD Electrophysiology Research Foundation
PRS Account Electrophysiology Research Foundation
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP