Transition of patients from blinded study drug to open-label anticoagulation: The ENGAGE AF-TIMI 48 trial

Journal of the American College of Cardiology

Volumn 64, Issue 6, 2014, Pages 576-584

  Ruff, Christian T ^a   Giugliano, Robert P ^a   Braunwald, Eugene ^a   Mercuri, Michele ^b   Curt, Valentin ^b   Betcher, Joshua ^c   Grip, Laura ^a   Cange, Abby L ^a   Crompton, Andrea E ^a   Murphy, Sabina A ^a   Deenadayalu, Naveen ^a   Antman, Elliott M ^a  

^a BRIGHAM AND WOMEN S HOSPITAL   (United States)

^b DAIICHI SANKYO INC   (United States)

^c IQVIA   (United States)

Author keywords

anticoagulation; atrial fibrillation; edoxaban; factor Xa inhibitor; new oral anticoagulants; vitamin K antagonist

Indexed keywords

ANTICOAGULATION; ATRIAL FIBRILLATION; EDOXABAN; FACTOR XA INHIBITOR; NEW ORAL ANTICOAGULANTS; VITAMIN K ANTAGONIST;

ADMINISTRATION, ORAL; AGED; ANTICOAGULANTS; ATRIAL FIBRILLATION; DOUBLE-BLIND METHOD; DRUG SUBSTITUTION; FACTOR XA; FEMALE; HUMANS; MALE; MIDDLE AGED; MYOCARDIAL INFARCTION; PYRIDINES; THIAZOLES; TREATMENT OUTCOME; WARFARIN;

EID: 84905683957     PISSN: 07351097     EISSN: 15583597     Source Type: Journal    
DOI: 10.1016/j.jacc.2014.05.028     Document Type: Article

References (18)

1. A.J. Camm, P. Kirchhof, and G.Y.H. Lip et al. Guidelines for the management of atrial fibrillation: the Task Force for the Management of Atrial Fibrillation of the European Society of Cardiology (ESC) Eur Heart J 31 2010 2369 2429
2. V. Fuster, L.E. Ryden, and D.S. Cannom et al. 2011 ACCF/AHA/HRS focused updates incorporated into the ACC/AHA/ESC 2006 guidelines for the management of patients with atrial fibrillation: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines J Am Coll Cardiol 57 2011 e100 e198
3. E.M. Hylek, A.S. Go, and Y. Chang et al. Effect of intensity of oral anticoagulation on stroke severity and mortality in atrial fibrillation N Engl J Med 349 2003 1019 1026
4. R.G. Hart, L.A. Pearce, and M.I. Aguilar Meta-analysis: antithrombotic therapy to prevent stroke in patients who have nonvalvular atrial fibrillation Ann Intern Med 146 2007 857 867
5. E. Birman-Deych, M.J. Radford, and D.S. Nilasena et al. Use and effectiveness of warfarin in Medicare beneficiaries with atrial fibrillation Stroke 37 2006 1070 1074
6. E.M. Hylek, C. Evans-Molina, and C. Shea et al. Major hemorrhage and tolerability of warfarin in the first year of therapy among elderly patients with atrial fibrillation Circulation 115 2007 2689 2696
7. S.J. Connolly, M.D. Ezekowitz, and S. Yusuf et al. Dabigatran versus warfarin in patients with atrial fibrillation N Engl J Med 361 2009 1139 1151
8. M.R. Patel, K.W. Mahaffey, and J. Garg et al. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation N Engl J Med 365 2011 883 891
9. C.B. Granger, J.H. Alexander, and J.J. McMurray et al. Apixaban versus warfarin in patients with atrial fibrillation N Engl J Med 365 2011 981 992
10. R.P. Giugliano, C.T. Ruff, and E. Braunwald et al. Edoxaban versus warfarin in patients with atrial fibrillation N Engl J Med 369 2013 2093 2104
11. K.W. Mahaffey, A.S. Hellkamp, and M.R. Patel et al. End of study transition from study drug to open-label vitamin K antagonist therapy: the ROCKET AF experience Circ Cardiovasc Qual Outcomes 6 2013 470 478
12. C.B. Granger, J.H. Alexander, and M. Hanna et al. Events after discontinuation of randomized treatment at the end of the ARISTOTLE trial Eur Heart J 33 Suppl 1 2012 685 686
13. S.J. Connolly, L. Wallentin, and M.D. Ezekowitz et al. The Long-Term Multicenter Observational Study of Dabigatran Treatment in Patients With Atrial Fibrillation (RELY-ABLE) study Circulation 128 2013 237 243
14. Xarelto [package insert]. Janssen Pharmaceuticals, Inc. Available at: http://www.xareltohcp.com/sites/default/files/pdf/xarelto-0.pdf#zoom=100? sitelink=Prescribing%20Information&utm-source=google&utm-medium= cpc&utm-campaign=Branded%20%20Phrase&utm-term=xarelto&utm-content= Xarelto|mkwid|swivGYlK4-dc|pcrid|34667838574. Accessed March 1, 2014.
15. Eliquis [package insert]. Bristol-Myers Squibb Company. Available at: http://packageinserts.bms.com/pi/pi-eliquis.pdf. Accessed March 1, 2014.
16. Pradaxa [package insert]. Boehringer Ingelheim Pharmaceuticals, Inc. Available at: http://bidocs.boehringer-ingelheim.com/BIWebAccess/ViewServlet. ser?docBase=renetnt&folderPath=/Prescribing%20Information/PIs/Pradaxa/ Pradaxa.pdf. Accessed March 1, 2014.
17. C.T. Ruff, R.P. Giugliano, and E.M. Antman et al. Evaluation of the novel factor xa inhibitor edoxaban compared with warfarin in patients with atrial fibrillation: design and rationale for the effective aNticoaGulation with factor xA next GEneration in atrial fibrillation-thrombolysis in myocardial infarction study 48 (ENGAGE AF-TIMI 48) Am Heart J 160 2010 635 641
18. S. Schulman, C. Kearon Subcommittee on Control of Anticoagulation of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients J Thromb Haemost 3 2005 692 694