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

NCT02561897 | Terminated Phase 4 Results DMC FDA Drug

• 1 other identifier: EPRF2015-01
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Major Bleeding

  Major local or systemic bleeding as defined in the protocol at 30 days after implant procedure

  Within 30 days of procedure

Secondary Outcomes (1)

• Thromboembolic and Cardiovascular Events

  Within 6 months of procedure

Study Arms (2)

Edoxaban

EXPERIMENTAL

Edoxaban 30 or 60 mg

Drug: Edoxaban

Warfarin

ACTIVE COMPARATOR

Warfarin 1 -1 0 mg

Drug: Warfarin

Interventions

Edoxaban DRUG

Also known as: Savaysa

Edoxaban

Warfarin DRUG

Warfarin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Electrophysiology Research Foundation: lead
• Axio Research Corporation: collaborator

Study Sites (1)

Electrophysiology Research Foundation

Warren Township, New Jersey, 07059, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

edoxaban; Warfarin

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Sanjeev Saksena
• Organization: Electrophysiology Research Foundation

eprf@aol.com

7323029990

Study Officials

• Sanjeev Saksena, MBBS MD

  Electrophysiology Research Foundation

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2015
• First Posted: September 28, 2015
• Study Start: December 1, 2015
• Primary Completion: September 1, 2017
• Study Completion: December 1, 2017
• Last Updated: June 30, 2020
• Results First Posted: February 10, 2020

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)