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.
Brief Title
EdoxabaN or Warfarin Therapy In Device Procedures in Patients With Non-Valvular Atrial Fibrillation
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.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Atrial Fibrillation
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
* 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
Inclusion 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
* 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
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT02561897
Org Class
Other
Org Full Name
Electrophysiology Research Foundation
Org Study Id
EPRF2015-01
Overall Status
Terminated
Phases
Phase 4
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Efficacy and Safety of Edoxaban or Warfarin Therapy In Cardiovascular Implantable Electrical Device Procedures in Patients With Non-valvular Atrial Fibrillation
Primary Outcomes
Outcome Description
Major local or systemic bleeding as defined in the protocol at 30 days after implant procedure
Outcome Measure
Major Bleeding
Outcome Time Frame
Within 30 days of procedure
Secondary Outcomes
Outcome Description
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
Outcome Time Frame
Within 6 months of procedure
Outcome Measure
Thromboembolic and Cardiovascular Events
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Luigi Dibiase
Investigator Email
ldibiase@montefiore.org
Investigator Phone
347-271-1637
Categories Mesh Debug
Heart/Cardiovascular --- ATRIAL FIBRILLATION
Heart/Cardiovascular --- ARRHYTHMIAS, CARDIAC
Brain, Spinal Cord & Nervous System --- HEART DISEASES
Heart/Cardiovascular --- HEART DISEASES
Blood Disorders --- CARDIOVASCULAR DISEASES
Blood & Bone Marrow Cancers --- CARDIOVASCULAR DISEASES
Heart/Cardiovascular --- CARDIOVASCULAR DISEASES
MeSH Terms
ATRIAL FIBRILLATION
ARRHYTHMIAS, CARDIAC
HEART DISEASES
CARDIOVASCULAR DISEASES
PATHOLOGIC PROCESSES
PATHOLOGICAL CONDITIONS, SIGNS AND SYMPTOMS
EDOXABAN
WARFARIN
4-HYDROXYCOUMARINS
COUMARINS
BENZOPYRANS
PYRANS
HETEROCYCLIC COMPOUNDS, 1-RING
HETEROCYCLIC COMPOUNDS
HETEROCYCLIC COMPOUNDS, 2-RING
HETEROCYCLIC COMPOUNDS, FUSED-RING