The aristotle trial nct00412984 design and results have been published. Phase 1 drug interaction study of apixaban and atenolol in healthy subjects the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Interventions apixaban therapy vs warfarin therapy. In conclusion, the aristotle trial will answer many important questions related to stroke prevention in af. A majority of the funding came from bristolmyers squibb. Randomized, doubleblind phase iii study active treatment. Apixaban for reduction in stroke and other thromboembolic. Pdf effects of apixaban compared with warfarin as gain. Apixaban for reduction in stroke and other thromboembolic events in atrial fibrillation aristotle trial. If noninferiority was met, the following endpoints were tested for superiority1,3. July 27, 2015 bloomberg reports that the fda delayed approving eliquis for nine months after finding evidence of major fraud and other problems at a chinese clinical trial site. Apixaban for reduction in stroke and other thromboembolic events. Aristotle will determine whether apixaban is noninferior or superior to warfarin in preventing stroke and systemic embolism.
Lopes rd1, alexander jh, alkhatib sm, ansell j, diaz r, easton jd, gersh bj, granger cb, hanna m, horowitz j, hylek em, mcmurray jj, verheugt fw, wallentin l. Apixaban 5 mg twice daily and clinical outcomes in patients. We investigated the impact of diabetes on outcomes and the effect of apixaban compared with warfarin in patients with atrial fibrillation with and without diabetes in the aristotle trial. From start to finish, aristotle provides political technology and the highest level of professionalism to ensure your message is voiced to the electorate. This trial studied major bleeding in people on eliquis and in people on placebo. Efficacy and safety of apixaban in patients after cardioversion for atrial fibrillation. This content is for healthcare professionals resident in the uk. Study design and objectives1 the primary objective of the trial was to determine if apixaban was noninferior to warfarin for the prevention of stroke and systemic embolism. To expand software description, mouse over the description. All analyses were performed using sas software version 9. Aristotle was an activecontrolled, randomized, doubleblind, multinational trial in patients with. In addition, there was a significant reduction in the risk of bleeding in patients treated with apixiban compared to warfarin. Article summarized results from the aristotle trial apixaban for reduction in stroke and other thromboembolic events in atrial fibrillation. Apixaban or matching placebo was dosed at 5 mg twice daily or 2.
Patients with af and at least 1 risk factor for stroke were randomized to receive either doseadjusted warfarin or apixaban, 5 mg twice daily. To download a desktop version, click the download arrow. The page includes a summary of phase iii clinical trials, an overview of indications under investigation by the different drugs and helpful services for patients and healthcare professionals. Apixaban vs warfarin in patients with atrial fibrillation. Apixaban compared with warfarin in patients with atrial. Bayesian optimal interval boin designs provide a novel platform to. Patients with afib and only one of the three dosereduction criteria used in the aristotle trialage 80 years or older, body weight 60 kg or less, and creatinine level 1. A pilot study stephanie carlin, jennifer pickering, and sam schulman abstract background.
Risk benefit of apixaban and other new oral anticoagulants. Fda delayed eliquis approval for fraud in chinese trial. Oct, 2014 phase 1 drug interaction study of apixaban and atenolol in healthy subjects the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Major bleeding in patients with atrial fibrillation. Request pdf apixaban for reduction in stroke and other thromboembolic events in atrial fibrillation aristotle trial. The trial was designed to test for noninferiority, with key secondary objec tives of testing for. Jul 29, 2016 patients with afib and only one of the three dosereduction criteria used in the aristotle trialage 80 years or older, body weight 60 kg or less, and creatinine level 1. Other agents, such as recombinant activated factor vii novoseven, novo nordisk as, bagsvaerd, denmark, have not been studied in this setting and are not recommended. Methods the biomarker substudy from the apixaban for reduction in stroke and other thromboembolic events in atrial fibrillation trial included 4850 patients with af randomised to treatment with apixaban or warfarin. Importance in the apixaban for reduction of stroke and other thromboembolic complications in atrial fibrillation aristotle trial, the standard dose of apixaban was 5 mg twice daily. Jun 21, 20 after the presentation and publication of the pivotal aristotle trial, the novel anticoagulant apixaban eliquis, pfizer and bristolmyers squibb was widely expected to be a blockbuster. Results of the averroes trial demonstrated superiority of apixaban, an oral xa inhibitor, over aspirin in preventing strokes in. You should receive your notification soon after your request. However, questions remain about the integrity of data.
Email address must be valid so instructions to access the software can be sent to you. Objectives compare the effect of apixaban and warfarin on coagulation and primary haemostasis biomarkers in atrial fibrillation af. Aristotle trial,7 we compared apixaban with warfarin for the. The aristotle trial design has been reported previously. Apixaban for the prevention of stroke in subjects with atrial. Apixaban, a factor xa inhibitor, was shown to reduce the risk of major hemorrhage by 31% compared with warfarin among patients with af in the aristotle apixaban for reduction in stroke and other thromboembolic events in atrial fibrillation trial. To access the software online click the red circle or the title. A new drug application nda for the approval of apixaban was submitted to the u.
Economic analysis of apixaban therapy for patients with. The aristotle trial randomized 18 201 af patients to apixaban 5 mg orally twice daily or warfarin target inr of 2. Please take a moment to register for your fully functional 15 day free trial. In the apixaban for reduction in stroke and other thromboembolic events in atrial fibrillation aristotle trial, 4. Results of the averroes trial demonstrated superiority of apixaban, an oral xa inhibitor, over aspirin in preventing strokes in patients with atrial fibrillation af. New eliquis apixaban posthoc subanalysis of the phase iii aristotle trial demonstrated that within 30 days of a procedure, stroke or systemic embolism and major bleeding were uncommon. The trial was designed to test for noninferiority, with key secondary objectives of testing for.
Apixaban versus warfarin in patients with atrial fibrillation. The aristotle trial showed that apixaban was superior to warfarin in. Methods all patients who received at least 1 dose of a study drug were included. Systematic overview and metaanalysis of clinical trials of apixaban.
Efficacy and safety of apixaban versus warfarin in. Wallentin believes the key to the success of aristotle was the. In doubleblind clinical trialslike this one for eliquisneither the patients nor the doctors conducting the trials know who is given placebo and who is given the actual medicinethe pills look the same. Apixaban was approved for medical use in the european union in may 2011. The details of the aristotle trial have been published. The aristotle trial apixaban for reduction in stroke and other thromboembolic events in atrial fibrillation. This trial studied major bleeding in people on eliquis and in. In a post hoc analysis of aristotle apixaban for reduction in stroke and other thromboembolic events in atrial fibrillation. Parkhomenko a, verheugt fw, zhu j, wallentin l, for the aristotle committees and investigators. The aristotle trial apixaban for reduction in stroke and other thromboembolic events in atrial fibrillation is summarized in this section including the primary endpoint and results. The aristotle study investigated apixaban, at a dose of 5 mg po bid, for the prevention of stroke in patients with atrial. Pdf effects of apixaban compared with warfarin as gain in. In aristotle, 18,201 patients were randomized 9,120 patients to eliquis and 9,081 to warfarin.
Subanalysis of phase iii aristotle trial of eliquis. Apixaban vs warfarin in patients with atrial fibrillation 1 apixaban for reduction in stroke and other thromboembolic events in atrial fibrillation. It is uncertain whether the benefit from apixaban varies by type and. Methods laplace regression was used to estimate the delay in time to the outcomes between the. Aristotle apixaban for the prevention of stroke insubjects with atrial fibrillationjjv mcmurray university of glasgow, scotlandeuropean society of cardiology heart failure congress 2012 an activecontrolled, randomized, doubleblind trial to compare the safety and efficacy of apixaban and warfarin in preventing stroke and systemic. It is 75% hepatically metabolized and the rest is renally excreted. Dont shy away from standard apixaban dose in certain highrisk patients.
Apixaban for reduction in stroke and other thromboembolic events in atrial. Apixaban for the prevention of stroke in subjects with. Aristotle clinical trial in aristotle, eliquis apixaban. The 2011 apixaban versus acetylsalicylic acid to prevent stroke in atrial fibrillation patients who have failed or are unsuitable for vitamin k antagonist treatment averroes trial randomized 5,599 patients with af thought to be unsuitable candidates for vka therapy to apixaban or aspirin. Apixaban to prevent stroke in patients with atrial. Information about apixaban vs warfarin for stroke prevention in nvaf aristotle trial. The aristotle study was designed to evaluate the efficacy and safety of eliquisversus warfarin for the prevention of stroke or systemic embolism. This website is a free of charge service from daiichi sankyo europe gmbh. Apixaban versus warfarin in patients with atrial fibrillation nejm. Pdf apixaban versus warfarin in patients with atrial fibrillation.
Aristotle s campaign solution epitomizes the aristotle experience. The 2011 apixaban for reduction in stroke and other thromboembolic events in atrial fibrillation aristotle trial randomized 18,201 patients with nonvalvular af and. Apixaban for reduction in stroke and other thromboembolic events in atrial fibrillation. Appropriateness of apixaban dosing to prevent stroke in patients with atrial fibrillation. Design the aristotle study was a randomized doubleblind trial comparing apixaban with warfarin.
Design, setting, and participants this economic analysis uses patientlevel resource use and clinical data collected in the aristotle trial, a multinational randomized clinical trial that observed 18 201 patients 3417 us patients for a median of 1. Background apixaban was shown to reduce the risk of major hemorrhage among patients with atrial fibrillation in the aristotle apixaban for reduction in stroke and other thromboembolic events in atrial fibrillation trial. Jul 16, 2012 aristotle apixaban for the prevention of stroke insubjects with atrial fibrillationjjv mcmurray university of glasgow, scotlandeuropean society of cardiology heart failure congress 2012 an activecontrolled, randomized, doubleblind trial to compare the safety and efficacy of apixaban and warfarin in preventing stroke and systemic. Apixaban vs warfarin the aristotle trial randomized 18 201 patients with af and at least one other risk factor to apixaban, given in. Appropriateness of apixaban dosing to prevent stroke in. Phase 1 drug interaction study of apixaban and atenolol in. Major bleeding in patients with atrial fibrillation receiving apixaban or warfarin. Major bleeding in patients with atrial fibrillation receiving. Predictors, characteristics, and clinical outcomes. Between dec 19, 2006, and april 2, 2010, patients were enrolled in the aristotle trial at 1034 clinical sites in 39 countries. Effect of apixaban compared with warfarin on coagulation. Aristotle trial and the recent fda approval of apixaban. China is becoming a popular country for large clinical trials because there are a lot of people and costs are lower. Listing a study does not mean it has been evaluated by the u.
New eliquis apixaban posthoc subanalysis of the phase iii. The primary objective of aristotle is to determine if the factor xa inhibitor, apixaban, is noninferior to warfarin at reducing the combined endpoint of stroke ischemic or hemorrhagic and systemic embolism in patients with af and at least 1 additional risk factor for stroke. Apixaban has no specific antidote or reversal agent. Bristolmyers squibb and pfizer to present new analyses of. Aristotle was an activecontrolled, randomized, doubleblind, multinational trial in patients with nonvalvular atrial fibrillation or atrial flutter, and at least one additional risk factor for stroke. Consistent benefit of apixaban across range of patient risk scores literature lopes rd et al. Clinical outcomes of patients with diabetes and atrial. Aristotle clinical trial in aristotle, eliquis apixaban demonstrated superior risk reduction in stroke systemic embolism with significantly less major bleeding vs. Food and drug administration fda by bristolmyers squibb bms and pfizer jointly after conclusion of the aristotle clinical trial in 2011. The trial demonstrated that apixaban is superior in preventing thromboembolic strokes in patients with atrial fibrillation when compared to warfarin hr 0. Mar 06, 2017 in aristotle, 18,201 patients were randomized 9,120 patients to eliquis and 9,081 to warfarin. The aristotle trial is led by an academic steering committee composed of 2 cochairs, national coordinators from each participating country, and a representative from the trial sponsor.
Efficacy and safety of apixaban versus warfarin in patients. The aristotle trial showed that apixaban was superior to warfarin in reducing stroke and systemic embolism in patients with af, with a better bleeding profile. Effects of apixaban compared with warfarin as gain in. After the presentation and publication of the pivotal aristotle trial, the novel anticoagulant apixaban eliquis, pfizer and bristolmyers squibb. Trial design and outcome measures the design of aristotle has been published. Dec 19, 2006 efficacy and safety of apixaban in patients after cardioversion for atrial fibrillation. Apixaban 5 mg twice daily and clinical outcomes in.