1. Edoxaban versus enoxaparin-warfarin in patients undergoing cardioversion of atrial fibrillation (ENSURE-AF): a randomised, open-label, phase 3b trial
- Author
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Goette, A, Merino, JL, Ezekowitz, MD, Zamoryakhin, D, Melino, M, Jin, J, Mercuri, MF, Grosso, MA, Fernandez, V, Al-Saady, N, Pelekh, N, Zenin, S, Batushkin, V, Lip, GYH, Weitz, J, Freemantle, N, Klein, H, Buller, H, Segers, A, Roos, Y, Slagboom, T, Thijs, V, van Mechelen, R, Larrey, D, Laleman, W, Heidbuchel, H, Goudev, A, Rasmussen, L, Le Heuzey, JY, Glikson, M, Banach, M, Ruda, M, Lundqvist, CB, Ezekowitz, M, Gwechenberger, M, Huber, K, Purerfellner, H, Roithinger, F, Scherr, D, Stuhlinger, M, Delforge, M, Rivero-Ayerza, M, Thoeng, J, Vervoort, G, Vijgen, J, Willems, R, Benov, H, Dimov, B, Nikolov, F, Godev, A, Jorgova-Makedonska, J, Lazov, P, Marchev, S, Mihov, L, Petranov, S, Raev, D, Stoyanov, M, Tarnovska-Kadreva, R, Todorov, G, Tumbev, H, Cermak, O, Slany, N, Jarkovsky, P, Kautzner, J, Lukac, B, Nadenickova, P, Peterka, K, Slaby, J, Spinar, J, Vesely, J, Vitovec, M, Zavada, F, Al-Hashimi, S, Bronnum-Schou, J, Egstrup, K, Frost, L, Gislason, G, Lomholdt, J, Malczynski, J, Moller, DS, Nielsen, T, Raymond, I, Riahi, S, Tuxen, C, Cohen, A, Cottin, Y, Defaye, P, Deharo, JC, Depuis, JM, Elbaz, M, Ferrari, E, Gosse, P, Goube, P, Paganelli, F, Pineau, J, Piot, O, Biermann, J, Bosch, R, Brachmann, J, Darius, H, Dengler, T, Hartmann, A, Kreis, I, Lamparter, S, Licka, M, Maier, L, Schellong, S, Schmitt, J, Stellbrink, C, Walkili, R, Willems, S, vom Dahl, J, Dezsi, A, Edes, I, Laszlo, S, Lupkovics, G, Matoltsy, A, Merkely, B, Nagy, A, Nagy, L, Palinkas, A, Simor, T, Tomcsanyi, J, Toth, L, Alcalai, R, Hayek, T, Katz, A, Mazen, E, Shechter, M, Shochat, M, Zeltser, D, Zimlichman, R, Boriani, G, De Caterina, R, Di Pasquale, G, Fattore, L, Grimaldi, M, Gulizia, M, Mazzone, C, Themistoclakis, S, Volpe, M, Allaart, C, de Groot, J, Elvan, A, Folkeringa, R, Hazeleger, R, Jansen, W, Nierop, P, Willems, A, de Ruiter, G, Czarnecka, D, Gniot, J, Januszewicz, A, Jaworska, K, Loboz-Grudzien, K, Niezgoda, K, Ptaszynski, P, Wysokinski, A, Bartos, D, Bengus, C, Bolohan, R, Chioncel, O, Coman, IM, Crisu, D, Dan, GA, Dobreanu, D, Dumitrescu, S, Gurghean, A, Lighezan, D, Militaru, C, Minescu, B, Podoleanu, CCG, Pop, C, Popescu, MI, Rosu, RO, Tase, A, Voicu, OC, Belenky, D, Bolshakova, O, Chumakova, G, Demko, A, Goloshchekin, B, Kostenko, V, Kuznetsov, V, Libov, I, Nevzorova, V, Nikolaev, K, Popov, S, Shubik, Y, Staroverov, I, Timofeev, A, Zrazhevskiy, K, Valladares, FA, Lopez, MA, Arenal, A, Gonzalez, VB, Cosin-Sales, J, Gonzalez-Juanatey, JR, Rubio, AM, Martinez, JG, Falconi, E, Mont, L, Bermejo, MAP, Sabate, X, Camano, MV, Vida, M, Vinolas, X, Gomez, JLZ, Lindquist, CB, Fredholm, O, Savelieva, I, Haywood, G, Aggarwal, R, Bakhai, A, Balasubramaniam, R, Betts, T, Campbell, P, Choy, AM, Davis, G, Izzat, L, Kadr, H, Lindsay, S, Lip, G, More, R, Ng, GA, Payne, G, Schilling, R, Senior, R, Tayebjee, M, Travill, C, Rishko, M, Fushtey, I, Karpenko, O, Karpenko, Y, Klantsa, A, Kraiz, I, Kushnir, M, Kutniy, O, Parkhomenko, A, Petrovskyy, R, Reshotko, D, Stanislavchuk, M, Sychov, O, Tseluyko, V, Vasylets, V, Minakova, PO, Volkov, D, Zharinov, O, Zhurba, S, Bahu, M, Bashir, F, Berk, M, Cheirif, J, Clay, A, Crenshaw, J, Ellenbogen, K, Ganeshram, V, Halpern, S, Heiman, M, Henderson, D, Ho, A, Kovach, T, Mckenzie, M, Nadar, V, Penny-Peterson, E, Rao, S, Sawhney, N, Shaoulian, E, Sheikh, K, Torres-Heisecke, R, and Weiss, R
- Abstract
Background Edoxaban, an oral factor Xa inhibitor, is non-inferior for prevention of stroke and systemic embolism in patients with atrial fibrillation and is associated with less bleeding than well controlled warfarin therapy. Few safety data about edoxaban in patients undergoing electrical cardioversion are available. Methods We did a multicentre, prospective, randomised, open-label, blinded-endpoint evaluation trial in 19 countries with 239 sites comparing edoxaban 60 mg per day with enoxaparin-warfarin in patients undergoing electrical cardioversion of non-valvular atrial fibrillation. The dose of edoxaban was reduced to 30 mg per day if one or more factors (creatinine clearance 15-50 mL/min, low bodyweight [
- Published
- 2016