atrial fibrillation - direct factor Xa inhibitors - all type of patients clinical trials results meta-analysis

<h1> <a href="index.html"> <strong>atrial fibrillation</strong> - direct factor Xa inhibitors </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="index.html"> edoxaban phase 2, 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 3 months<br> n=1146/0<br> Parallel groups<br> double-blind <br> USA, Europe, South and central america, </td> </tr> <tr> <td> <a href="index.html"> ROCKET-AF, 2010 </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=7131/7133<br> Parallel groups<br> double blind <br> 45 countries </td> </tr> <tr> <td> <a href="index.html"> AVERROES, 2011 </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 maximum 21 months<br> n=2808/2791<br> Parallel groups<br> double blind <br> 36 countries </td> </tr> <tr> <td> <a href="index.html"> phase 2 apixaban, 0 </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> <tr> <td> <a href="index.html"> EXPLORE-Xa, 2010 </a> <br> NCT00742859 </td> <td> three doses of betrixaban (40 mg, n = 127; 60 mg, n = 127; 80 mg, n = 127)<br> <i>versus</i> <br> dose-adjusted warfarin INR 2-3 </td> <td> patients with nonvalvular atrial fibrillation </td> <td> follow-up 4.9 mo (median) (3-12mo)<br> n=381/127<br> Parallel groups<br> double-blind <br> </td> </tr> <tr> <td> <a href="index.html"> phase 2 YM150, 0 </a> <br> NCT00448214 </td> <td> YM150 ASTELLAS<br> <i>versus</i> <br> warfarin </td> <td> subjects with non-valvular atrial fibrillation </td> <td> follow-up <br> n=-9/-9<br> Parallel groups<br> open <br> Australia </td> </tr> <tr> <td> <a href="index.html"> phase 2 edoxaban, 0 </a> <br> NCT00829933 </td> <td> edoxaban (DU-176b) 30 mg once daily, 30 mg twice daily, 60 mg once daily or 60 mg twice daily<br> <i>versus</i> <br> warfarin </td> <td> patients with non-valvular atrial fibrillation and a CHADS2 index >=2 </td> <td> follow-up <br> n=-9/-9<br> Parallel groups<br> double-blind <br> Japan </td> </tr> <tr> <td> <a href="index.html"> phase 2 edoxaban, 0 </a> <br> NCT00806624 </td> <td> edoxaban (DU-176b)<br> <i>versus</i> <br> warfarin </td> <td> male and female subjects aged 18 to 80 years, inclusive, with non-valvular AF and a CHADS2 Score of at least 1 </td> <td> follow-up <br> n=-9/-9<br> Parallel groups<br> double-blind <br> China </td> </tr> <tr> <td> <a href="index.html"> 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="index.html"> 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="index.html"> OPAL-2, </a> <br> NCT00938730 </td> <td> YM150<br> <i>versus</i> <br> warfarin </td> <td> subjects with non-valvular atrial fibrillation </td> <td> follow-up <br> n=-9/-9<br> <br> double-blind <br> Australia </td> </tr> <tr> <td> <a href="index.html"> ROCKET J, </a> <br> NCT00494871 </td> <td> Rivaroxaban<br> <i>versus</i> <br> warfarin </td> <td> </td> <td> follow-up <br> n=-9/-9<br> parallel groups<br> double-blind <br> Japan </td> </tr> </table> <h2>References</h2> <p> <b>ROCKET-AF, 2010 : </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>ENGAGE-AF TIMI 48, : </b> Ruff CT, Giugliano RP, Antman EM, Crugnale SE, Bocanegra T, Mercuri M, Hanyok J, Patel I, Shi M, Salazar D, McCabe CH, Braunwald EEvaluation 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). <i>Am Heart J 2010;160:635-41</i> [PMID 20934556] 10.1016/j.ahj.2010.06.042 </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, 2011 : </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> <p> <b>AVERROES, 2011 : </b> 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 FApixaban in Patients with Atrial Fibrillation. <i>N Engl J Med 2011 Feb 10;:</i> [PMID 21309657] 10.1056/NEJMoa1007432 </p> <p> <b>phase 2 edoxaban, 0 : </b> Weitz JI. #33 <i> 50th Annual meeting of the American Society of Hematology; Dec. 5-9, 2008; San Francisco.</i> [PMID ] </p>