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

<h1> <a href="index.html"> <strong>atrial fibrillation</strong> - new oral anticoagulants </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"> 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="index.html"> 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="index.html"> 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="index.html"> 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="index.html"> 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="index.html"> Weitz (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 median 1.94 y<br> n=7131/7133<br> Parallel groups<br> double blind <br> 45 countries </td> </tr> <tr> <td> <a href="index.html"> AMADEUS, 2008 </a> <br> NCT00070655 </td> <td> subcutaneous idraparinux 2�5 mg weekly<br>  <i>versus</i> <br> adjusted-dose vitamin K antagonists (target of an international normalised ratio of 2�3) </td> <td> patients with atrial fi brillation at risk for thromboembolism </td> <td> follow-up 10.7 months<br> n=2283/2293<br> Parallel groups<br> open <br> </td> </tr> <tr> <td> <a href="index.html"> ENGAGE-AF TIMI 48 High dose, 2013 </a> <br> NCT00781391 </td> <td> edoxaban 60mg once daily<br>  <i>versus</i> <br> warfarin (INR 2-3) </td> <td> AF patients (CHADS2 >=2) </td> <td> follow-up 2.8 years<br> n=7035/7036<br> Parallel groups<br> double blind <br> 46 countries </td> </tr> <tr> <td> <a href="index.html"> 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="index.html"> ARISTOTLE, 2011 </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 1.8 yrs (median)<br> n=9120/9081<br> Parallel groups<br> double blind <br> 39 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"> 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> 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"> Lip (phase 2 AZD0837), 2009 </a> <br> NCT00684307 </td> <td> AZD0837 for 3-9 months<br>  <i>versus</i> <br> dose-adjusted Vitamin-K antagonists (VKA) (aiming for an international normalized ratio (INR) 2.0 to 3.0) </td> <td> patients with non-valvular atrial fibrillation (AF) with one or more additional risk factors for stroke </td> <td> follow-up 3 or 9 months<br> n=636/318<br> Parallel groups<br> double blind <br> </td> </tr> <tr> <td> <a href="index.html"> phase 2 AZD0837, 0 </a> <br> NCT00623779 </td> <td> AZD0837<br>  <i>versus</i> <br> aspirin </td> <td> patients with atrial fibrillation, who are appropriate for but unable or unwilling to take Vitamin-K antagonist(VKA) therapy </td> <td> follow-up <br> n=-9/-9<br> Parallel groups<br> open <br> </td> </tr> <tr> <td> <a href="index.html"> phase 2 dabigatran, 0 </a> <br> NCT01136408 </td> <td> Dabigatran 110, 220, 300 mg twice daily<br>  <i>versus</i> <br> warfarin </td> <td> patients with non-valvular atrial fibrillation (paroxysmal, persistent or permanent) </td> <td> follow-up <br> n=-9/-9<br> Parallel groups<br> open <br> Japan </td> </tr> <tr> <td> <a href="index.html"> idraparinux BOREALIS-AF, 0 </a> <br> NCT00580216 </td> <td> idraparinuxonce-weekly subcutaneous injection<br>  <i>versus</i> <br> warfarin oral INR adjusted-dose </td> <td> </td> <td> follow-up <br> n=-9/-9<br> Parallel groups<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>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 Sep 17;361:1139-51</i> [PMID 19717844] 10.1056/NEJMoa0905561 </p> <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>ROCKET-AF, 2010 : </b> 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 RMRivaroxaban versus Warfarin in Nonvalvular Atrial Fibrillation. <i>N Engl J Med 2011 Aug 10;:</i> [PMID 21830957] 10.1056/NEJMoa1009638 </p> <p> <b>AMADEUS, 2008 : </b> Bousser MG, Bouthier J, B�ller HR, Cohen AT, Crijns H, Davidson BL, Halperin J, Hankey G, Levy S, Pengo V, Prandoni P, Prins MH, Tomkowski W, Thorp-Pedersen C, Wyse DGComparison of idraparinux with vitamin K antagonists for prevention of thromboembolism in patients with atrial fibrillation: a randomised, open-label, non-inferiority trial. <i>Lancet 2008;371:315-21</i> [PMID 18294998] </p> <p> <b>ENGAGE-AF TIMI 48 High dose, 2013 : </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>ENGAGE-AF TIMI 48 High dose, 2013 : </b> Giugliano RP, Ruff CT, Braunwald E, Murphy SA, Wiviott SD, Halperin JL, Waldo AL, Ezekowitz MD, Weitz JI, �pinar J, Ruzyllo W, Ruda M, Koretsune Y, Betcher J, Shi M, Grip LT, Patel SP, Patel I, Hanyok JJ, Mercuri M, Antman EMEdoxaban versus warfarin in patients with atrial fibrillation. <i>N Engl J Med 2013 Nov 28;369:2093-104</i> [PMID 24251359] </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, 2011 : </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>ARISTOTLE, 2011 : </b> 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 JApixaban versus Warfarin in Patients with Atrial Fibrillation. <i>N Engl J Med 2011 Aug 27;:</i> [PMID 21870978] 10.1056/NEJMoa1107039 </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> <p> <b>Lip (phase 2 AZD0837), 2009 : </b> Lip GY, Rasmussen LH, Olsson SB, Jensen EC, Persson AL, Eriksson U, W�hlander KFOral direct thrombin inhibitor AZD0837 for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation: a randomized dose-guiding, safety, and tolerability study of four doses of AZD0837 vs. vitamin K antagonists. <i>Eur Heart J 2009;30:2897-907</i> [PMID 19690349] 10.1093/eurheartj/ehp318 </p>