This is a prospective, randomized, open-label, blinded end-point evaluation trial. The patient population consists of patients on hemodialysis who have atrial fibrillation (AF) and end-stage renal disease (ESRD) .
This is a multicenter study in adult patients with AF and ESRD who are on hemodialysis and who have stroke risk factors making them candidates for oral anticoagulation. Patients will be randomized to apixaban versus warfarin, and will be treated for up to 15 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
154
Number of Participants Experiencing ISTH (International Society on Thrombosis and Haemostasis) Major or Clinically Relevant Non-major Bleeding
Assess the safety of apixaban versus warfarin regarding ISTH major bleeding or clinically relevant non-major bleeding events in patients with NVAF (nonvalvular atrial fibrillation) and ESRD (end-stage renal disease) on hemodialysis. Major bleeding event is defined as:Acute clinically overt bleeding (including access site related bleeding) accompanied by 1 or more of the following: Decrease in Hgb of 2g/dL or more with overt bleeding; Transfusion of 2 or more units of packed RBCs in the setting of an overt bleeding event; Bleeding within a critical site. Hemorrhagic stroke (primary or infarction with hemorrhagic conversion) were classified as major bleeds. Non-major bleeding event is defined as: Acute or sub-acute clinically overt bleeding (including access site related bleeding) that does not meet criteria for major bleeding \& results in Hospital admission for bleeding, physician guided medical or surgical treatment for bleeding, or change in antithrombotic therapy
Time frame: Randomization up to Month 15/Final Visit
Number of Participants Experiencing Stroke or Systemic Embolism
Number of participants experiencing adjudicated stroke or systemic embolism.
Time frame: Randomization up to Month 15/Final Visit
Number of Participants Experiencing Mortality
Evaluate mortality rates for those participants randomized to warfarin and apixaban in patients with NVAF and ESRD on hemodialysis
Time frame: Randomization up to Month 15/Final Visit
Persistence of Therapy
Evaluate days between time from initiation to discontinuation of randomized therapy.
Time frame: Randomization up to Month 15/Final Visit
Apixaban Plasma Concentration, Cmax
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Nephrology Consultants
Huntsville, Alabama, United States
The Medical Research Group, Inc.
Fresno, California, United States
DaVita Clinical Trials, LLC
Long Beach, California, United States
Southland Renal Medical Group
Long Beach, California, United States
Valley Renal Medical Group Research
Northridge, California, United States
Summit Nephrology Medical Group, Inc.
Roseville, California, United States
Satellite Healthcare
San Jose, California, United States
Washington Nephrology Associates
Washington D.C., District of Columbia, United States
South Florida Nephrology Group PA, Research Division
Coral Springs, Florida, United States
LG. Diagnostic, Inc. & Cosmetic Center
Miami, Florida, United States
...and 48 more locations
Evaluate the pharmacokinetics of apixaban in ESRD NVAF patients on hemodialysis. The measurement was done from 0-12 hours after the dose was given on Day 1.
Time frame: 0-12 hours post-dose
Apixaban Plasma Concentration, Cmin
Evaluate the pharmacokinetics of apixaban in ESRD NVAF patients on hemodialysis. The measurement was done from 0-12 hours after the dose was given on Day 1.
Time frame: 0-12 hours post-dose
Area Under the Plasma Apixaban Concentration Curve From 0 to 12 Hours After Dose (AUCO-12)
Evaluate the pharmacokinetics of apixaban in ESRD NVAF patients on hemodialysis. The measurement was done from 0 to 12 hours after dose was given on Day 1.
Time frame: 0-12 hours post-dose
Apixaban Pharmacodynamics, Chromogenic Factor Xa Assay
Evaluate the pharmacodynamics of apixaban in ESRD NVAF patients on hemodialysis
Time frame: Baseline: Day 3, 4, or 5; Day 28
Adherence to Treatment With Apixaban or With Warfarin
Measured by self-reported days of medication compliance over the last 30 days.
Time frame: Month 15/Final Visit