| Outcome Measures: |
Primary: 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, Randomization up to Month 15/Final Visit | Secondary: Number of Participants Experiencing Stroke or Systemic Embolism, Number of participants experiencing adjudicated stroke or systemic embolism., 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, Randomization up to Month 15/Final Visit|Persistence of Therapy, Evaluate days between time from initiation to discontinuation of randomized therapy., Randomization up to Month 15/Final Visit|Apixaban Plasma Concentration, Cmax, 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., 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., 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., 0-12 hours post-dose|Apixaban Pharmacodynamics, Chromogenic Factor Xa Assay, Evaluate the pharmacodynamics of apixaban in ESRD NVAF patients on hemodialysis, 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., Month 15/Final Visit | Other: Number of Participants Experiencing Systemic Embolism, Adjudicated diagnosis of systemic arterial embolism (Non-pulmonary, non-cranial events) will require a positive clinical history consistent with an acute loss of blood flow to a peripheral artery (or arteries), which is supported by evidence of embolism/thrombosis from surgical specimens, autopsy, angiography, vascular imaging, or other objective testing. Clinical presentation would include: 1. Abrupt development of pain, absent pulses, pallor, and/or paresis in an extremity (at least an entire digit) without previous severe claudication or findings of severe peripheral vascular disease. 2. Renal embolism will be diagnosed when sudden flank pain or a change in renal laboratory findings occurred. 3. Abdominal vascular/visceral embolism was considered definite if acute abdominal symptoms or referred symptoms developed along with a change in abdominal examination or appropriate laboratory values., Randomization up to Month 15/Final Visit|Number of Participants Experiencing Stroke, Adjudcated stroke defined as a new, non-traumatic episode of focal or global neurological dysfunction of sudden onset caused by central nervous system (CNS) vascular injury as a result of hemorrhage or infarction and not due to a readily identifiable non-vascular cause (i.e. brain tumor). CNS includes brain, spinal cord and retina. The required duration of the deficit is ≥ 24 hours. * Events with neurologic deficit lasting for \< 24 hours and an imaging modality showing evidence of an acute stroke will be counted as stroke as well. * A retinal ischemic event (embolism, infarction) will be considered a stroke, Randomization up to Month 15/Final Visit|Number of Participants Experiencing Stroke, Systemic Embolism, Major Bleeding or All-cause Mortality, Evaluate those experiencing stroke, systemic embolism, ISTH major bleeding, or all-cause mortality for those randomized to warfarin and apixaban in patients with NVAF and ESRD on hemodialysis Definitions of stroke and systemic embolism are provided under the measurement description of the secondary outcomes for each individual event. Definition of major bleed is provided in outcome measurement description of the primary outcome measure., Randomization up to Month 15/Final Visit|Baseline Biomarkers, Analysis of outcomes and treatment effect according to levels of cardiovascular biomarkers at baseline, Baseline
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| Locations: |
Nephrology Consultants, Huntsville, Alabama, 35805, United States|The Medical Research Group, Inc., Fresno, California, 93720, United States|DaVita Clinical Trials, LLC, Long Beach, California, 90806, United States|Southland Renal Medical Group, Long Beach, California, 90806, United States|Valley Renal Medical Group Research, Northridge, California, 91324, United States|Summit Nephrology Medical Group, Inc., Roseville, California, 95661, United States|Satellite Healthcare, San Jose, California, 95126, United States|Washington Nephrology Associates, Washington, District of Columbia, 20010, United States|South Florida Nephrology Group PA, Research Division, Coral Springs, Florida, 33071, United States|LG. Diagnostic, Inc. & Cosmetic Center, Miami, Florida, 33126, United States|Nuren Medical and Research Center, Miami, Florida, 33144, United States|Medical Professional Clinical Research Center, Miami, Florida, 33165, United States|Boise Kidney and Hypertension Institute, Meridian, Idaho, 83642, United States|Northwestern University, Chicago, Illinois, 60611, United States|NANI Research, Crystal Lake, Illinois, 60014, United States|NANI Research, River Forest, Illinois, 60305, United States|NANI Research, Fort Wayne, Indiana, 46804, United States|Northwest Louisiana Nephrology, Shreveport, Louisiana, 71101, United States|Anne Arundel Medical Center, Annapolis, Maryland, 21401, United States|The Johns Hopkins University, Baltimore, Maryland, 21224, United States|Washington Nephrology Associates, Takoma Park, Maryland, 20912, United States|Massachusetts General Hospital, Boston, Massachusetts, 02114, United States|South Shore Nephrology, Plymouth, Massachusetts, 02360, United States|Renal and Transplant Associates of New England, Springfield, Massachusetts, 01107, United States|Paragon Health Neprhology Centre, Kalamazoo, Michigan, 49007, United States|St. Clair Nephrology, Port Huron, Michigan, 48060, United States|Mayo Clinic, Rochester, Minnesota, 55905, United States|Southwest Mississippi Nephrology, PLLC, Brookhaven, Mississippi, 39601, United States|Southern Clinical Research Group, LLC, Gulfport, Mississippi, 39501, United States|Nephrology & Hypertension Associates, Tupelo, Mississippi, 38801, United States|Polack Renal, LLC, Saint Louis, Missouri, 63136, United States|Sierra Nevada Nephrology Consultants, Reno, Nevada, 89511, United States|Renal Medicine Associates, Albuquerque, New Mexico, 87109, United States|Advanced Kidney Care of Hudson Valley, Poughkeepsie, New York, 12601, United States|Durham Nephrology Associates, Durham, North Carolina, 27704, United States|East Carolina University, Greenville, North Carolina, 27834, United States|Eastern Nephrology Associates, PLLC., Kinston, North Carolina, 28504, United States|Eastern Nephrology Associates, PLLC, New Bern, North Carolina, 28562, United States|HNC Dialysis, Ltd., Columbus, Ohio, 43215, United States|Northeast Clinical Research Ctr, Bethlehem, Pennsylvania, 18017, United States|Penn State Health - Milton S. Hershey Medical Center, Hershey, Pennsylvania, 17033, United States|Rhode Island Hospital, Providence, Rhode Island, 02903, United States|Columbia Nephrology Associates, Columbia, South Carolina, 29203, United States|South Carolina Nephrology and Hypertension, Orangeburg, South Carolina, 29118, United States|Sumter Medical Specialists, Sumter, South Carolina, 29150, United States|Regional Health Clinical Research, Rapid City, South Dakota, 57701, United States|Knoxville Kidney Center, Knoxville, Tennessee, 37923, United States|Southwest Houston Research, Ltd., Houston, Texas, 77099, United States|Lubbock Vascular Access Center, Lubbock, Texas, 79416, United States|University of Utah, Salt Lake City, Utah, 84112, United States|Washington Nephrology Associates, Alexandria, Virginia, 22304, United States|University of Virgina Health System, Charlottesville, Virginia, 22908, United States|TPMG Clinical Research, Newport News, Virginia, 23606, United States|Valley Nephrology Associates, Roanoke, Virginia, 24014, United States|University of Washington, Seattle, Washington, 98104, United States|Nephrology and Hypertension Associates, Bluefield, West Virginia, 24701, United States|West Virginia University, Morgantown, West Virginia, 26506, United States|Aspirius Research Institute, Wausau, Wisconsin, 54401, United States
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