atrial fibrillation - new oral anticoagulant - all type of patients clinical trials results meta-analysis

<h1> <a href="TM10-136-new oral anticoagulant-atrial fibrillation" > <strong>atrial fibrillation</strong> - new oral anticoagulant </a> - all type of patients trial results systematic overview and meta-analysis </h1> <h2>Main characteristics of the included studies</h2> <table> <tr> <th>Trial</th> <th>Treatments</th> <th>Patients</th> <th>Methods</th> </tr> <tr> <td> <a href="../TRC_t2636.htm"> SPORTIF II (ximelagatran vs warfarin standard dose), 2002 </a> <br> </td> <td> ximelegatran 20,40,60 mg twice daily<br>  <i>versus</i> <br> warfarin standard dose(target INR 2-3) </td> <td> Medium to high risk patients with chronic non valvular atrial fibrillation. </td> <td> follow-up 16 weeks<br> n=187/67<br> Parallel groups<br> Open <br> Europe ,USA </td> </tr> <tr> <td> <a href="../TRC_t2637.htm"> SPORTIF III , 2003 </a> <br> </td> <td> ximelagatran 36 mg twice daily<br>  <i>versus</i> <br> warfarin standard dose (target INR 2-3) </td> <td> One or more stroke risk factor in addition to AF.High risk patients with non valvular atrial fibrillation. </td> <td> follow-up 17.4 months<br> n=1704/1703<br> Parallel groups<br> Open <br> europe,asia,australasia </td> </tr> <tr> <td> <a href="../TRC_t2638.htm"> SPORTIF V , 2005 </a> <br> </td> <td> ximelegatran 36 mg twice daily<br>  <i>versus</i> <br> warfarin standard dose(target INR 2-3) </td> <td> One or more stroke risk factor in addition to atrial fibrillation.High risk patients with non valvular atrial fibrillation. </td> <td> follow-up 20 months<br> n=1960/1962<br> Parallel groups<br> Double blind <br> north america </td> </tr> <tr> <td> <a href="../TRC_t7217.htm"> PETRO (150mg), 2007 </a> <br> </td> <td> dabigatran 150 mg twice daily (alone or combined with 81- or 325-mg aspirin)<br>  <i>versus</i> <br> warfarin administered to achieve an international normalized ratio of 2 to 3 for </td> <td> patients with AF at high risk for thromboembolic events </td> <td> follow-up 12 weeks<br> n=166/70<br> Factorial plan<br> double blind <br> Denmark, The netehrlands, Sweden, US </td> </tr> <tr> <td> <a href="../TRC_t7218.htm"> RE-LY (150mg), 2009 </a> <br> NCT00262600 </td> <td> dabigatran 150 mg twice a day<br>  <i>versus</i> <br> warfarin adjusted-dose to a 2.0 to 3.0 INR </td> <td> Patients With Non-Valvular Atrial Fibrillation </td> <td> follow-up 2 y (median)<br> n=6076/6022<br> Parallel groups<br> open (blind assessment) <br> 44 countries </td> </tr> <tr> <td> <a href="../TRC_t9892.htm"> RE-LY (110mg), 2009 </a> <br> NCT00262600 </td> <td> dabigatran 110 mg twice a day <br>  <i>versus</i> <br> warfarin adjusted dose to a 2-3 INR </td> <td> Patients With Non-Valvular Atrial Fibrillation </td> <td> follow-up 2 y (median)<br> n=6015/6022<br> Parallel groups<br> open (blind assessment) <br> 44 countries </td> </tr> <tr> <td> <a href="../TRC_t7219.htm"> NCT00504556, 0 </a> <br> NCT00504556 </td> <td> Four Fixed Dose Regimens of edoxaban (DU-176b)<br>  <i>versus</i> <br> warfarin </td> <td> Subjects With Non- Valvular Atrial Fibrillation </td> <td> follow-up <br> n=-9/-9<br> <br> <br> </td> </tr> <tr> <td> <a href="../TRC_t7222.htm"> ROCKET-AF (NCT00403767), 0 </a> <br> NCT00403767 </td> <td> Rivaroxaban 20mg p.o. once daily<br>  <i>versus</i> <br> Warfarin p.o. once daily titrated to a target INR of 2.5 (range 2.0 to 3.0, inclusive) </td> <td> Subjects With Non-Valvular Atrial Fibrillation </td> <td> follow-up up to 4 y<br> n=14266/0<br> Parallel groups<br> double blind <br> </td> </tr> <tr> <td> <a href="../TRC_t9825.htm"> ENGAGE-AF TIMI 48, </a> <br> NCT00781391 </td> <td> edoxaban 30 or 60mg once daily<br>  <i>versus</i> <br> warfarin (INR 2-3) </td> <td> AF patients (CHADS2 >=2) </td> <td> follow-up 24 months<br> n=-9/-9<br> Parallel groups<br> double blind <br> </td> </tr> <tr> <td> <a href="../TRC_t10002.htm"> NCT00494871, </a> <br> NCT00494871 </td> <td> rivaroxaban 10mg daily<br>  <i>versus</i> <br> warfarin adjusted dose </td> <td> Japanese patients with non-valvular atrial fibrillation </td> <td> follow-up <br> n=1280/0<br> Parallel groups<br> double blind <br> Japan </td> </tr> <tr> <td> <a href="../TRC_t10339.htm"> ARISTOTLE (CV185-030), </a> <br> NCT00412984 </td> <td> apixaban 5mg twice daily <br>  <i>versus</i> <br> warfarin adjusted for an INR between 2 and 3 </td> <td> subjects with atrial fibrillation and risk factors for stroke </td> <td> follow-up <br> n=18183/0<br> <br> double blind <br> </td> </tr> <tr> <td> <a href="../TRC_t10340.htm"> AVERROES (CV185-048), </a> <br> NCT00496769 </td> <td> apixaban 5 mg (or 2.5 mg) twice daily<br>  <i>versus</i> <br> aspirin 81-324 md daily </td> <td> patients with atrial fibrillation who have failed or are unsuitable for vitamin K antagonist treatment </td> <td> follow-up up to 36 mo<br> n=-9/-9<br> Parallel groups<br> double blind <br> 36 countries </td> </tr> <tr> <td> <a href="../TRC_t10341.htm"> B0661003, </a> <br> NCT00787150 </td> <td> apixaban 5 or 2.5 mg twice daily<br>  <i>versus</i> <br> warfarin </td> <td> patient with non valvular AF </td> <td> follow-up 12 weeks<br> n=222/0<br> Parallel groups<br> double blind <br> </td> </tr> </table> <h2>References</h2> <p> <b>SPORTIF II (ximelagatran vs warfarin standard dose), 2002 : </b> Petersen P, Grind M, Adler JXimelagatran versus warfarin for stroke prevention in patients with nonvalvular atrial fibrillation. SPORTIF II: a dose-guiding, tolerability, and safety study. <i>J Am Coll Cardiol 2003 May 7;41:1445-51</i> [PMID 12742279] </p> <p> <b>SPORTIF III , 2003 : </b> Olsson SBStroke prevention with the oral direct thrombin inhibitor ximelagatran compared with warfarin in patients with non-valvular atrial fibrillation (SPORTIF III): randomised controlled trial. <i>Lancet 2003 Nov 22;362:1691-8</i> [PMID 14643116] </p> <p> <b>SPORTIF V , 2005 : </b> Halperin JLXimelagatran compared with warfarin for prevention of thromboembolism in patients with nonvalvular atrial fibrillation: Rationale, objectives, and design of a pair of clinical studies and baseline patient characteristics (SPORTIF III and V). <i>Am Heart J 2003 Sep;146:431-8</i> [PMID 12947359] </p> <p> <b>SPORTIF V , 2005 : </b> Albers GW, Diener HC, Frison L, Grind M, Nevinson M, Partridge S, Halperin JL, Horrow J, Olsson SB, Petersen P, Vahanian AXimelagatran vs warfarin for stroke prevention in patients with nonvalvular atrial fibrillation: a randomized trial. <i>JAMA 2005 Feb 9;293:690-8</i> [PMID 15701910] </p> <p> <b>PETRO (150mg), 2007 : </b> Ezekowitz MD, Reilly PA, Nehmiz G, Simmers TA, Nagarakanti R, Parcham-Azad K, Pedersen KE, Lionetti DA, Stangier J, Wallentin LDabigatran with or without concomitant aspirin compared with warfarin alone in patients with nonvalvular atrial fibrillation (PETRO Study). <i>Am J Cardiol 2007;100:1419-26</i> [PMID 17950801] </p> <p> <b>RE-LY (150mg), 2009 : </b> Ezekowitz MD, Connolly S, Parekh A, Reilly PA, Varrone J, Wang S, Oldgren J, Themeles E, Wallentin L, Yusuf SRationale and design of RE-LY: randomized evaluation of long-term anticoagulant therapy, warfarin, compared with dabigatran. <i>Am Heart J 2009;157:805-10, 810.e1-2</i> [PMID 19376304] </p> <p> <b>RE-LY (150mg), 2009 : </b> 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 LDabigatran versus Warfarin in Patients with Atrial Fibrillation. <i>N Engl J Med 2009 Aug 30;:</i> [PMID 19717844] 10.1056.NEJM0a0905561 </p> <p> <b>ROCKET-AF (NCT00403767), 0 : </b> 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. <i>Am Heart J 2010;159:340-347.e1</i> [PMID 20211293] 10.1016/j.ahj.2009.11.025 </p> <p> <b>RE-LY (110mg), 2009 : </b> Ezekowitz MD, Connolly S, Parekh A, Reilly PA, Varrone J, Wang S, Oldgren J, Themeles E, Wallentin L, Yusuf S <i>Am Heart J 2009;157:805-10, 810.e1-2</i> [PMID 19376304] </p> <p> <b>RE-LY (110mg), 2009 : </b> 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 LDabigatran versus Warfarin in Patients with Atrial Fibrillation. <i>N Engl J Med 2009 Aug 30;:</i> [PMID 19717844] 10.1056.NEJM0a0905561 </p> <p> <b>ARISTOTLE (CV185-030), : </b> Lopes RD, Alexander JH, Al-Khatib SM, Ansell J, Diaz R, Easton JD, Gersh BJ, Granger CB, Hanna M, Horowitz J, Hylek EM, McMurray JJ, Verheugt FW, Wallentin LApixaban for reduction in stroke and other ThromboemboLic events in atrial fibrillation (ARISTOTLE) trial: design and rationale. <i>Am Heart J 2010;159:331-9</i> [PMID 20211292] 10.1016/j.ahj.2009.07.035 </p> <p> <b>AVERROES (CV185-048), : </b> Eikelboom JW, O'Donnell M, Yusuf S, Diaz R, Flaker G, Hart R, Hohnloser S, Joyner C, Lawrence J, Pais P, Pogue J, Synhorst D, Connolly SJRationale and design of AVERROES: apixaban versus acetylsalicylic acid to prevent stroke in atrial fibrillation patients who have failed or are unsuitable for vitamin K antagonist treatment. <i>Am Heart J 2010;159:348-353.e1</i> [PMID 20211294] 10.1016/j.ahj.2009.08.026 </p>