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

NCT ID: NCT02561897

Last Updated: 2020-06-30

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2017-12-31

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.

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Edoxaban

Edoxaban 30 or 60 mg

Group Type: EXPERIMENTAL

Edoxaban

Intervention Type: DRUG

Warfarin

Warfarin 1 -1 0 mg

Group Type: ACTIVE_COMPARATOR

Warfarin

Intervention Type: DRUG

Interventions

Edoxaban

Intervention Type: DRUG

Warfarin

Intervention Type: DRUG

Other Intervention Names

Savaysa

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Axio Research Corporation

INDUSTRY

Sponsor Role: collaborator

Electrophysiology Research Foundation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sanjeev Saksena, MBBS MD

Role: STUDY_CHAIR

Electrophysiology Research Foundation

Locations

Electrophysiology Research Foundation

Warren Township, New Jersey, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

EPRF2015-01

Identifier Type: -

Identifier Source: org_study_id