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

Phase 4TerminatedNCT02561897

Electrophysiology Research Foundation5 enrolled

Overview

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

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Atrial Fibrillation

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

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