Apixaban was approved for medical use in the european union in may 2011. In aristotle, 18,201 patients were randomized 9,120 patients to eliquis and 9,081 to warfarin. 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. 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. If noninferiority was met, the following endpoints were tested for superiority1,3. Systematic overview and metaanalysis of clinical trials of apixaban. Article summarized results from the aristotle trial apixaban for reduction in stroke and other thromboembolic events in atrial fibrillation. 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 versus warfarin in patients with atrial fibrillation nejm. Email address must be valid so instructions to access the software can be sent to you. Efficacy and safety of apixaban versus warfarin in patients. 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. 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. 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.
Subanalysis of phase iii aristotle trial of eliquis. Aristotle will determine whether apixaban is noninferior or superior to warfarin in preventing stroke and systemic embolism. Apixaban 5 mg twice daily and clinical outcomes in. Methods all patients who received at least 1 dose of a study drug were included. 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. Apixaban for reduction in stroke and other thromboembolic events. China is becoming a popular country for large clinical trials because there are a lot of people and costs are lower.
Apixaban for reduction in stroke and other thromboembolic events in atrial. You should receive your notification soon after your request. This content is for healthcare professionals resident in the uk. Interventions apixaban therapy vs warfarin therapy. Pdf apixaban versus warfarin in patients with atrial fibrillation. In addition, there was a significant reduction in the risk of bleeding in patients treated with apixiban compared to warfarin. Trial design and outcome measures the design of aristotle has been published. Results of the averroes trial demonstrated superiority of apixaban, an oral xa inhibitor, over aspirin in preventing strokes in. Predictors, characteristics, and clinical outcomes. Apixaban versus warfarin in patients with atrial fibrillation. Apixaban 5 mg twice daily and clinical outcomes in patients. This trial studied major bleeding in people on eliquis and in people on placebo. To download a desktop version, click the download arrow.
Appropriateness of apixaban dosing to prevent stroke in patients with atrial fibrillation. Major bleeding in patients with atrial fibrillation receiving. 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. 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. Between dec 19, 2006, and april 2, 2010, patients were enrolled in the aristotle trial at 1034 clinical sites in 39 countries.
Apixaban for the prevention of stroke in subjects with. Details of the aristotle trial have been published. 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. 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 aristotle trial showed that apixaban was superior to warfarin in reducing stroke and systemic embolism in patients with af, with a better bleeding profile. A majority of the funding came from bristolmyers squibb. 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. Major bleeding in patients with atrial fibrillation receiving apixaban or warfarin. 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. Apixaban or matching placebo was dosed at 5 mg twice daily or 2. However, questions remain about the integrity of data. Pdf effects of apixaban compared with warfarin as gain.
The trial demonstrated that apixaban is superior in preventing thromboembolic strokes in patients with atrial fibrillation when compared to warfarin hr 0. Dec 19, 2006 efficacy and safety of apixaban in patients after cardioversion for atrial fibrillation. Request pdf apixaban for reduction in stroke and other thromboembolic events in atrial fibrillation aristotle trial. 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. Randomized, doubleblind phase iii study active treatment. A pilot study stephanie carlin, jennifer pickering, and sam schulman abstract background.
The aristotle trial showed that apixaban was superior to warfarin in. Apixaban has no specific antidote or reversal agent. Aristotle was an activecontrolled, randomized, doubleblind, multinational trial in patients with. The trial was designed to test for noninferiority, with key secondary objec tives of testing for. The aristotle study was designed to evaluate the efficacy and safety of eliquisversus warfarin for the prevention of stroke or systemic embolism. Apixaban compared with warfarin in patients with atrial. Bristolmyers squibb and pfizer to present new analyses of. Bayesian optimal interval boin designs provide a novel platform to. Effects of apixaban compared with warfarin as gain in. It is uncertain whether the benefit from apixaban varies by type and. Economic analysis of apixaban therapy for patients with. Efficacy and safety of apixaban versus warfarin in. 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. Fda delayed eliquis approval for fraud in chinese trial.
Wallentin believes the key to the success of aristotle was the. Parkhomenko a, verheugt fw, zhu j, wallentin l, for the aristotle committees and investigators. Results of the averroes trial demonstrated superiority of apixaban, an oral xa inhibitor, over aspirin in preventing strokes in patients with atrial fibrillation af. Efficacy and safety of apixaban in patients after cardioversion for atrial fibrillation. Dont shy away from standard apixaban dose in certain highrisk patients. A new drug application nda for the approval of apixaban was submitted to the u. 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. The aristotle trial apixaban for reduction in stroke and other thromboembolic events in atrial fibrillation. Mar 06, 2017 in aristotle, 18,201 patients were randomized 9,120 patients to eliquis and 9,081 to warfarin. Consistent benefit of apixaban across range of patient risk scores literature lopes rd et al. Major bleeding in patients with atrial fibrillation.
Objectives compare the effect of apixaban and warfarin on coagulation and primary haemostasis biomarkers in atrial fibrillation af. Please take a moment to register for your fully functional 15 day free trial. 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. This trial studied major bleeding in people on eliquis and in. 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. Apixaban for the prevention of stroke in subjects with atrial.
All analyses were performed using sas software version 9. Phase 1 drug interaction study of apixaban and atenolol in. 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. To access the software online click the red circle or the title. The trial was designed to test for noninferiority, with key secondary objectives of testing for. The details of the aristotle trial have been published. The aristotle trial design has been reported previously. Apixaban for reduction in stroke and other thromboembolic. Apixaban for reduction in stroke and other thromboembolic events in atrial fibrillation.
Aristotle s campaign solution epitomizes the aristotle experience. 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. The aristotle study investigated apixaban, at a dose of 5 mg po bid, for the prevention of stroke in patients with atrial. 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. After the presentation and publication of the pivotal aristotle trial, the novel anticoagulant apixaban eliquis, pfizer and bristolmyers squibb. Apixaban to prevent stroke in patients with atrial. From start to finish, aristotle provides political technology and the highest level of professionalism to ensure your message is voiced to the electorate. It is 75% hepatically metabolized and the rest is renally excreted. Aristotle clinical trial in aristotle, eliquis apixaban. Aristotle trial,7 we compared apixaban with warfarin for the. Apixaban vs warfarin in patients with atrial fibrillation. In conclusion, the aristotle trial will answer many important questions related to stroke prevention in af. In a post hoc analysis of aristotle apixaban for reduction in stroke and other thromboembolic events in atrial fibrillation.
Methods laplace regression was used to estimate the delay in time to the outcomes between the. Clinical outcomes of patients with diabetes and atrial. Appropriateness of apixaban dosing to prevent stroke in. Apixaban vs warfarin in patients with atrial fibrillation 1 apixaban for reduction in stroke and other thromboembolic events in atrial fibrillation. The aristotle trial randomized 18 201 af patients to apixaban 5 mg orally twice daily or warfarin target inr of 2. Design the aristotle study was a randomized doubleblind trial comparing apixaban with warfarin. The aristotle trial nct00412984 design and results have been published. The 2011 apixaban for reduction in stroke and other thromboembolic events in atrial fibrillation aristotle trial randomized 18,201 patients with nonvalvular af and.
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 expand software description, mouse over the description. 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. Listing a study does not mean it has been evaluated by the u. New eliquis apixaban posthoc subanalysis of the phase iii. This website is a free of charge service from daiichi sankyo europe gmbh. Pdf effects of apixaban compared with warfarin as gain in.
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