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Trial record 87 of 734 for:    warfarin

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

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ClinicalTrials.gov Identifier: NCT02561897
Recruitment Status : Terminated (Did not meet enrolment target for phase 1)
First Posted : September 28, 2015
Last Update Posted : March 10, 2017
Sponsor:
Collaborator:
Axio Research Corporation
Information provided by (Responsible Party):
Electrophysiology Research Foundation

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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Drug: Edoxaban Drug: Warfarin Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 4, Randomized, Open Label, Multicenter, Prospective Comparative Study to Evaluate the Efficacy and Safety of Edoxaban or Warfarin Therapy In Cardiovascular Implantable Electrical Device Procedures in Patients With Non-valvular Atrial Fibrillation
Actual Study Start Date : December 2015
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Edoxaban
Edoxaban 30 or 60 mg
Drug: Edoxaban
Other Name: Savaysa

Active Comparator: Warfarin
Warfarin 1 -1 0 mg
Drug: Warfarin



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02561897


Locations
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United States, New Jersey
Electrophysiology Research Foundation
Warren, New Jersey, United States, 07059
Sponsors and Collaborators
Electrophysiology Research Foundation
Axio Research Corporation
Investigators
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Study Chair: Sanjeev Saksena, MBBS MD Electrophysiology Research Foundation

Additional Information:
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Responsible Party: Electrophysiology Research Foundation
ClinicalTrials.gov Identifier: NCT02561897     History of Changes
Other Study ID Numbers: EPRF2015-01
First Posted: September 28, 2015    Key Record Dates
Last Update Posted: March 10, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Warfarin
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Edoxaban
Anticoagulants
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action