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 :
(Did not meet enrolment target for phase 1)
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
Drug: EdoxabanDrug: Warfarin
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.
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 :
Estimated Primary Completion Date :
Estimated Study Completion Date :
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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 :
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
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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