End of study transition from study drug to open-label vitamin K antagonist therapy : the ROCKET AF experience

Circulation: Cardiovascular Quality and Outcomes

Volumn 6, Issue 4, 2013, Pages 470-478

  Mahaffey, Kenneth W ^a   Hellkamp, Anne S ^a   Patel, Manesh R ^a   Hannan, Karen L ^a   Schwabe, Kimberly ^c   Nessel, Christopher C ^c   Berkowitz, Scott D ^d   Halperin, Jonathan L ^e   Hankey, Graeme J ^f   Becker, Richard C ^a   Piccini, Jonathan P ^a   Breithardt, Günter ^g   Hacke, Werner ^h   Singer, Daniel E ⁱ   Califf, Robert M ^b   Fox, Keith A A ^j  

^a DUKE UNIVERSITY MEDICAL CENTER   (United States)

^b DUKE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^c JOHNSON AND JOHNSON PHARMACEUTICAL RESEARCH AND DEVELOPMENT   (United States)

^d BAYER CORPORATION   (United States)

^e MOUNT SINAI MEDICAL CENTER   (United States)

^f ROYAL PERTH HOSPITAL   (Australia)

^g UNIVERSITY HOSPITAL MÜNSTER   (Germany)

^h UNIVERSITY OF HEIDELBERG   (Germany)

ⁱ MASSACHUSETTS GENERAL HOSPITAL   (United States)

^j UNIVERSITY OF EDINBURGH   (United Kingdom)

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Author keywords

Atrial fibrillation; Bridging; Discontinuations; Factor Xa; Randomized controlled trial; Rivaroxaban; Stroke

Indexed keywords

ANTIVITAMIN K; ENOXAPARIN; HEPARIN; LOW MOLECULAR WEIGHT HEPARIN; RIVAROXABAN; WARFARIN;

ADULT; AGED; ANTICOAGULATION; ARTICLE; CEREBROVASCULAR ACCIDENT; COMORBIDITY; CREATININE CLEARANCE; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; FEMALE; FOLLOW UP; HEART ATRIUM FIBRILLATION; HUMAN; INTERNATIONAL NORMALIZED RATIO; KIDNEY FUNCTION; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; OPEN STUDY; PRIORITY JOURNAL; THROMBOEMBOLISM; TRANSIENT ISCHEMIC ATTACK; TREATMENT OUTCOME;

ATRIAL FIBRILLATION; BRIDGING; DISCONTINUATIONS; FACTOR XA; RANDOMIZED CONTROLLED TRIAL; RIVAROXABAN; STROKE;

AGED; AGED, 80 AND OVER; ANTICOAGULANTS; ATRIAL FIBRILLATION; BLOOD COAGULATION; CLINICAL PROTOCOLS; CONTINUITY OF PATIENT CARE; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; DRUG SUBSTITUTION; EMBOLISM; FACTOR XA; FEMALE; HUMANS; INTERNATIONAL NORMALIZED RATIO; MALE; MIDDLE AGED; MORPHOLINES; PROPORTIONAL HAZARDS MODELS; RESEARCH DESIGN; RISK FACTORS; STROKE; THIOPHENES; TIME FACTORS; TREATMENT OUTCOME; VITAMIN K; WARFARIN;

EID: 84884492931     PISSN: 19417713     EISSN: 19417705     Source Type: Journal    
DOI: 10.1161/CIRCOUTCOMES.113.000132     Document Type: Article

References (12)

1. Go AS, Hylek EM, Phillips KA, Chang Y, Henault LE, Selby JV, Singer DE. Prevalence of diagnosed atrial fibrillation in adults: national implications for rhythm management and stroke prevention: the Anticoagulation and Risk Factors in Atrial Fibrillation (ATRIA) study. JAMA. 2001;285:2370-2375.
2. ROCKET AF Study Investigators. Rivaroxaban-once daily, oral, direct factor Xa inhibition compared with vitamin K antagonism for prevention of stroke and Embolism Trial in Atrial Fibrillation: rationale and design of the ROCKET AF study. Am Heart J. 2010;159:340-347.
3. Patel MR, Mahaffey KW, Garg J, Pan G, Singer DE, Hacke W, Breithardt G, Halperin JL, Hankey GJ, Piccini JP, Becker RC, Nessel CC, Paolini JF, Berkowitz SD, Fox KA, Califf RM; ROCKET AF Investigators. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med. 2011;365:883-891.
4. U.S. Food and Drug Administration. XARELTO (Rivaroxaban) tablets. Risk Evaluation and Mitigation Strategy (REMS). http://www.fda.gov/downloads/Drugs/ DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM295405.pdf? utm-source=fdaSearch&utm-medium=website&utm-term=Rivaroxaban box warning&utm-content=1. Accessed April 4, 2012.
5. Patel MR, Hellkamp AS, Lokhnygina Y, Piccini JP, Zhang Z, Mohanty S, Singer DE, Hacke W, Breithardt G, Halperin JL, Hankey GJ, Becker RC, Nessel CC, Berkowitz SD, Califf RM, Fox KAA, Mahaffey KW. Outcomes of discontinuing rivaroxaban compared with warfarin in patients with nonvalvular atrial fibrillation: analysis from the ROCKET AF trial. J Am Coll Cardiol. 2013;61:651-658.
6. FDA Approves Xarelto to Reduce Risk of Blood Clots After Hip, Knee Replacements [News Release]. Silver Spring, MD: US Food & Drug Administration; 2011. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ ucm261839.htm. Accessed July 10, 2012.
7. Connolly SJ, Ezekowitz MD, Yusuf S, Eikelboom J, Oldgren J, Parekh A, Pogue J, Reilly PA, Themeles E, Varrone J, Wang S, Alings M, Xavier D, Zhu J, Diaz R, Lewis BS, Darius H, Diener HC, Joyner CD, Wallentin L. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009;361:1139-1151.
8. 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. Apixaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2011;365:981-992.
9. Hori M, Matsumoto M, Tanahashi N, Momomura S, Uchiyama S, Goto S, Izumi T, Koretsune Y, Kajikawa M, Kato M, Ueda H, Iwamoto K, Tajiri M; J-ROCKET AF study investigators. Rivaroxaban vs. warfarin in Japanese patients with atrial fibrillation-the J-ROCKET AF study. Circ J. 2012;76:2104-2111.
10. Gage BF, Waterman AD, Shannon W, Boechler M, Rich MW, Radford MJ. Validation of clinical classification schemes for predicting stroke: results from the National Registry of Atrial Fibrillation. JAMA. 2001;285:2864-2870.
11. Go AS, Hylek EM, Chang Y, Phillips KA, Henault LE, Capra AM, Jensvold NG, Selby JV, Singer DE. Anticoagulation therapy for stroke prevention in atrial fibrillation: how well do randomized trials translate into clinical practice? JAMA. 2003;290:2685-2692.
12. Harrison RW, Ortel TL, Becker RC. To bridge or not to bridge: these are the questions. J Thromb Thrombolysis. 2012;34:31-35.