Trial to Evaluate Anticoagulation Therapy in Hemodialysis Patients With Atrial Fibrillation
NCT ID: NCT02942407
Last Updated: 2020-12-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
154 participants
INTERVENTIONAL
2016-12-31
2019-08-12
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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apixaban
apixaban 5 mg twice daily (apixaban 2.5 mg twice daily for selected patients)
apixaban
oral anticoagulant
warfarin
warfarin daily dose adjusted to target International Normalized Ration(INR) of 2-3
warfarin
oral anticoagulant
Interventions
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apixaban
oral anticoagulant
warfarin
oral anticoagulant
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients with AF defined as AF on ECG at enrollment or two or more reports of AF from separate monitoring events at least 2 weeks apart (report of ECG, Holter monitor, event monitor or implantable loop recorder).
* CHA2DS2-VASc score of ≥ 2.
* End-stage renal disease treated with hemodialysis for ≥ 3 months.
* Considered by the treating physician(s) to be candidate for oral anticoagulation.
* If of childbearing potential, be willing to avoid pregnancy during the study.
Exclusion Criteria
* Moderate or severe mitral stenosis
* Conditions other than AF that require anticoagulation such as mechanical prosthetic valve, deep venous thrombosis, or pulmonary embolism
* Need for aspirin at a dose \> 81 mg a day or need for P2Y12 antagonist therapy (for example clopidogrel, prasugrel, or ticagrelor)
* Life expectancy \< 3 months
* Anticipated kidney transplant within the next 3 months
* Prisoners or others who are involuntarily incarcerated or detained
* Pregnant, breastfeeding, or considering pregnancy.
* Participation in a clinical trial of an experimental treatment within the past 30 days
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Christopher Granger, MD
OTHER
Responsible Party
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Christopher Granger, MD
Professor of Medicine
Principal Investigators
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Christopher Granger, MD
Role: PRINCIPAL_INVESTIGATOR
Duke University
Glenn Chertow, MD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
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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
Nuren Medical and Research Center
Miami, Florida, United States
Medical Professional Clinical Research Center
Miami, Florida, United States
Boise Kidney and Hypertension Institute
Meridian, Idaho, United States
Northwestern University
Chicago, Illinois, United States
NANI Research
Crystal Lake, Illinois, United States
NANI Research
River Forest, Illinois, United States
NANI Research
Fort Wayne, Indiana, United States
Northwest Louisiana Nephrology
Shreveport, Louisiana, United States
Anne Arundel Medical Center
Annapolis, Maryland, United States
The Johns Hopkins University
Baltimore, Maryland, United States
Washington Nephrology Associates
Takoma Park, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
South Shore Nephrology
Plymouth, Massachusetts, United States
Renal and Transplant Associates of New England
Springfield, Massachusetts, United States
Paragon Health Neprhology Centre
Kalamazoo, Michigan, United States
St. Clair Nephrology
Port Huron, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Southwest Mississippi Nephrology, PLLC
Brookhaven, Mississippi, United States
Southern Clinical Research Group, LLC
Gulfport, Mississippi, United States
Nephrology & Hypertension Associates
Tupelo, Mississippi, United States
Polack Renal, LLC
St Louis, Missouri, United States
Sierra Nevada Nephrology Consultants
Reno, Nevada, United States
Renal Medicine Associates
Albuquerque, New Mexico, United States
Advanced Kidney Care of Hudson Valley
Poughkeepsie, New York, United States
Durham Nephrology Associates
Durham, North Carolina, United States
East Carolina University
Greenville, North Carolina, United States
Eastern Nephrology Associates, PLLC.
Kinston, North Carolina, United States
Eastern Nephrology Associates, PLLC
New Bern, North Carolina, United States
HNC Dialysis, Ltd.
Columbus, Ohio, United States
Northeast Clinical Research Ctr
Bethlehem, Pennsylvania, United States
Penn State Health - Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Columbia Nephrology Associates
Columbia, South Carolina, United States
South Carolina Nephrology and Hypertension
Orangeburg, South Carolina, United States
Sumter Medical Specialists
Sumter, South Carolina, United States
Regional Health Clinical Research
Rapid City, South Dakota, United States
Knoxville Kidney Center
Knoxville, Tennessee, United States
Southwest Houston Research, Ltd.
Houston, Texas, United States
Lubbock Vascular Access Center
Lubbock, Texas, United States
University of Utah
Salt Lake City, Utah, United States
Washington Nephrology Associates
Alexandria, Virginia, United States
University of Virgina Health System
Charlottesville, Virginia, United States
TPMG Clinical Research
Newport News, Virginia, United States
Valley Nephrology Associates
Roanoke, Virginia, United States
University of Washington
Seattle, Washington, United States
Nephrology and Hypertension Associates
Bluefield, West Virginia, United States
West Virginia University
Morgantown, West Virginia, United States
Aspirius Research Institute
Wausau, Wisconsin, United States
Countries
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References
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Wizemann V, Tong L, Satayathum S, Disney A, Akiba T, Fissell RB, Kerr PG, Young EW, Robinson BM. Atrial fibrillation in hemodialysis patients: clinical features and associations with anticoagulant therapy. Kidney Int. 2010 Jun;77(12):1098-106. doi: 10.1038/ki.2009.477. Epub 2010 Jan 6.
Olesen JB, Lip GY, Kamper AL, Hommel K, Kober L, Lane DA, Lindhardsen J, Gislason GH, Torp-Pedersen C. Stroke and bleeding in atrial fibrillation with chronic kidney disease. N Engl J Med. 2012 Aug 16;367(7):625-35. doi: 10.1056/NEJMoa1105594.
Nigwekar SU, Bhan I, Turchin A, Skentzos SC, Hajhosseiny R, Steele D, Nazarian RM, Wenger J, Parikh S, Karumanchi A, Thadhani R. Statin use and calcific uremic arteriolopathy: a matched case-control study. Am J Nephrol. 2013;37(4):325-32. doi: 10.1159/000348806. Epub 2013 Mar 21.
Yang F, Chou D, Schweitzer P, Hanon S. Warfarin in haemodialysis patients with atrial fibrillation: what benefit? Europace. 2010 Dec;12(12):1666-72. doi: 10.1093/europace/euq387. Epub 2010 Nov 2.
Chan KE, Lazarus JM, Thadhani R, Hakim RM. Warfarin use associates with increased risk for stroke in hemodialysis patients with atrial fibrillation. J Am Soc Nephrol. 2009 Oct;20(10):2223-33. doi: 10.1681/ASN.2009030319. Epub 2009 Aug 27.
Shah M, Avgil Tsadok M, Jackevicius CA, Essebag V, Eisenberg MJ, Rahme E, Humphries KH, Tu JV, Behlouli H, Guo H, Pilote L. Warfarin use and the risk for stroke and bleeding in patients with atrial fibrillation undergoing dialysis. Circulation. 2014 Mar 18;129(11):1196-203. doi: 10.1161/CIRCULATIONAHA.113.004777. Epub 2014 Jan 22.
Granger CB, Chertow GM. A pint of sweat will save a gallon of blood: a call for randomized trials of anticoagulation in end-stage renal disease. Circulation. 2014 Mar 18;129(11):1190-2. doi: 10.1161/CIRCULATIONAHA.113.007549. Epub 2014 Jan 22. No abstract available.
Chan KE, Edelman ER, Wenger JB, Thadhani RI, Maddux FW. Dabigatran and rivaroxaban use in atrial fibrillation patients on hemodialysis. Circulation. 2015 Mar 17;131(11):972-9. doi: 10.1161/CIRCULATIONAHA.114.014113. Epub 2015 Jan 16.
Hart RG, Pearce LA, Asinger RW, Herzog CA. Warfarin in atrial fibrillation patients with moderate chronic kidney disease. Clin J Am Soc Nephrol. 2011 Nov;6(11):2599-604. doi: 10.2215/CJN.02400311. Epub 2011 Sep 8.
Reinecke H, Brand E, Mesters R, Schabitz WR, Fisher M, Pavenstadt H, Breithardt G. Dilemmas in the management of atrial fibrillation in chronic kidney disease. J Am Soc Nephrol. 2009 Apr;20(4):705-11. doi: 10.1681/ASN.2007111207. Epub 2008 Dec 17.
Hart RG, Pearce LA, Aguilar MI. Meta-analysis: antithrombotic therapy to prevent stroke in patients who have nonvalvular atrial fibrillation. Ann Intern Med. 2007 Jun 19;146(12):857-67. doi: 10.7326/0003-4819-146-12-200706190-00007.
Winkelmayer WC, Liu J, Setoguchi S, Choudhry NK. Effectiveness and safety of warfarin initiation in older hemodialysis patients with incident atrial fibrillation. Clin J Am Soc Nephrol. 2011 Nov;6(11):2662-8. doi: 10.2215/CJN.04550511. Epub 2011 Sep 29.
Hohnloser SH, Hijazi Z, Thomas L, Alexander JH, Amerena J, Hanna M, Keltai M, Lanas F, Lopes RD, Lopez-Sendon J, Granger CB, Wallentin L. Efficacy of apixaban when compared with warfarin in relation to renal function in patients with atrial fibrillation: insights from the ARISTOTLE trial. Eur Heart J. 2012 Nov;33(22):2821-30. doi: 10.1093/eurheartj/ehs274. Epub 2012 Aug 29.
Elliott MJ, Zimmerman D, Holden RM. Warfarin anticoagulation in hemodialysis patients: a systematic review of bleeding rates. Am J Kidney Dis. 2007 Sep;50(3):433-40. doi: 10.1053/j.ajkd.2007.06.017.
Wu JR, DeWalt DA, Baker DW, Schillinger D, Ruo B, Bibbins-Domingo K, Macabasco-O'Connell A, Holmes GM, Broucksou KA, Erman B, Hawk V, Cene CW, Jones CD, Pignone M. A single-item self-report medication adherence question predicts hospitalisation and death in patients with heart failure. J Clin Nurs. 2014 Sep;23(17-18):2554-64. doi: 10.1111/jocn.12471. Epub 2013 Dec 20.
Gonzalez JS, Schneider HE, Wexler DJ, Psaros C, Delahanty LM, Cagliero E, Safren SA. Validity of medication adherence self-reports in adults with type 2 diabetes. Diabetes Care. 2013 Apr;36(4):831-7. doi: 10.2337/dc12-0410. Epub 2012 Nov 30.
Halvorsen S, Atar D, Yang H, De Caterina R, Erol C, Garcia D, Granger CB, Hanna M, Held C, Husted S, Hylek EM, Jansky P, Lopes RD, Ruzyllo W, Thomas L, Wallentin L. Efficacy and safety of apixaban compared with warfarin according to age for stroke prevention in atrial fibrillation: observations from the ARISTOTLE trial. Eur Heart J. 2014 Jul 21;35(28):1864-72. doi: 10.1093/eurheartj/ehu046. Epub 2014 Feb 20.
Fox KA, Piccini JP, Wojdyla D, Becker RC, Halperin JL, Nessel CC, Paolini JF, Hankey GJ, Mahaffey KW, Patel MR, Singer DE, Califf RM. Prevention of stroke and systemic embolism with rivaroxaban compared with warfarin in patients with non-valvular atrial fibrillation and moderate renal impairment. Eur Heart J. 2011 Oct;32(19):2387-94. doi: 10.1093/eurheartj/ehr342. Epub 2011 Aug 28.
Farrington CP, Manning G. Test statistics and sample size formulae for comparative binomial trials with null hypothesis of non-zero risk difference or non-unity relative risk. Stat Med. 1990 Dec;9(12):1447-54. doi: 10.1002/sim.4780091208.
Connolly SJ, Eikelboom J, Joyner C, Diener HC, Hart R, Golitsyn S, Flaker G, Avezum A, Hohnloser SH, Diaz R, Talajic M, Zhu J, Pais P, Budaj A, Parkhomenko A, Jansky P, Commerford P, Tan RS, Sim KH, Lewis BS, Van Mieghem W, Lip GY, Kim JH, Lanas-Zanetti F, Gonzalez-Hermosillo A, Dans AL, Munawar M, O'Donnell M, Lawrence J, Lewis G, Afzal R, Yusuf S; AVERROES Steering Committee and Investigators. Apixaban in patients with atrial fibrillation. N Engl J Med. 2011 Mar 3;364(9):806-17. doi: 10.1056/NEJMoa1007432. Epub 2011 Feb 10.
Granger CB, Alexander JH, McMurray JJ, Lopes RD, Hylek EM, Hanna M, Al-Khalidi HR, Ansell J, Atar D, Avezum A, Bahit MC, Diaz R, Easton JD, Ezekowitz JA, Flaker G, Garcia D, Geraldes M, Gersh BJ, Golitsyn S, Goto S, Hermosillo AG, Hohnloser SH, Horowitz J, Mohan P, Jansky P, Lewis BS, Lopez-Sendon JL, Pais P, Parkhomenko A, Verheugt FW, Zhu J, Wallentin L; ARISTOTLE Committees and Investigators. Apixaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2011 Sep 15;365(11):981-92. doi: 10.1056/NEJMoa1107039. Epub 2011 Aug 27.
Herzog CA, Asinger RW, Berger AK, Charytan DM, Diez J, Hart RG, Eckardt KU, Kasiske BL, McCullough PA, Passman RS, DeLoach SS, Pun PH, Ritz E. Cardiovascular disease in chronic kidney disease. A clinical update from Kidney Disease: Improving Global Outcomes (KDIGO). Kidney Int. 2011 Sep;80(6):572-86. doi: 10.1038/ki.2011.223. Epub 2011 Jul 13.
Pokorney SD, Chertow GM, Al-Khalidi HR, Gallup D, Dignacco P, Mussina K, Bansal N, Gadegbeku CA, Garcia DA, Garonzik S, Lopes RD, Mahaffey KW, Matsuda K, Middleton JP, Rymer JA, Sands GH, Thadhani R, Thomas KL, Washam JB, Winkelmayer WC, Granger CB; RENAL-AF Investigators. Apixaban for Patients With Atrial Fibrillation on Hemodialysis: A Multicenter Randomized Controlled Trial. Circulation. 2022 Dec 6;146(23):1735-1745. doi: 10.1161/CIRCULATIONAHA.121.054990. Epub 2022 Nov 6.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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United States Renal Data System Web Site
Other Identifiers
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Pro00068545
Identifier Type: -
Identifier Source: org_study_id