The lowdose edoxaban arm was evaluated but not approved. This study will provide data that may guide the optimal management of triple antithrombotic therapy. Apixaban for extended treatment of venous thromboembolism. A total of 5,400 patients were enrolled and randomized to treatment with apixaban or conventional therapy i. Bristolmyers squibb and pfizer to present new analyses of.
Prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation. For apixaban, the usual dose is 5 mg bid with a dose reduction to 2. The details of the aristotle trial have been published. Apr 29, 2020 eliquis contains the active substance apixaban and belongs to a group of medicines called anticoagulants. Uw medicine alternative monitoring for antithrombotic agents.
Eliquis 5 mg filmcoated tablets summary of product. Pink, oval tablets debossed with 894 on one side and 5 on the other side. Apixaban is an oral anticoagulant currently approved for prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, for the treatment of deep vein thrombosis and pulmonary embolism, and for the prophylaxis of systemic embolism after orthopedic surgery. To perform a subgroup analysis to compare the efficacy and safety of apixaban and enoxaparin followed by warfarin for the treatment of vte in patients with cancer enrolled in amplify. The apixaban for reduction of stroke and other thromboembolic complications in atrial fibrillation aristotle trial compared apixaban with warfarin in 18 201 patients with af and at least 1 risk factor for stroke. This draft guidance, when finalized, will represent the.
Economic analysis of apixaban therapy for patients with. Specifically it is used to prevent blood clots following hip or knee replacement and in those with a history of prior clots. Tell any doctor or dentist that you are on apixaban before any medical procedures including operations in hospital, minor procedures at gp or dental clinics. September 1, 2017 apixaban lowers the risk of stroke compared to warfarin in anticoagulationnaive patients with atrial fibrillation scheduled for elective cardioversion, according to latebreaking results from the emanate trial presented in a hot line lbct session at esc congress. Averroes trial, a randomized, doubleblind, multinational superiority trial where apixaban was compared to aspirin in patients considered unsuitable for warfarin.
The eu clinical trials register currently displays 37010 clinical trials with a eudract protocol, of which 6096 are clinical trials conducted with subjects less than 18 years old. You may want to think about taking part in a clinical trial. The register also displays information on 18700 older paediatric trials in scope of article. It is used as an alternative to warfarin and does not require monitoring. Eliquis 5 mg filmcoated tablets patient information leaflet pil.
Highlights of prescribing information these highlights do not include all the information needed to use eliquis safely and effectively. The current trial extends those findings, and demonstrates superiority for strokesystemic embolism with apixaban compared with warfarin, with a better bleeding profile. Apixaban, sold under the brand name eliquis among others, is an anticoagulant medication used to treat and prevent blood clots and to prevent stroke in people with nonvalvular atrial fibrillation. Apixaban for the acute treatment of venous thromboembolism in. If anticoagulation with eliquis must be discontinued for a reason other. Apixaban for treatment of embolic stroke of undetermined. In a clinical trial, eliquis was tested against lovenox enoxaparin followed by warfarin lovenox warfarin, a standard treatment, for the first 6 months after dvtpe. Mar 06, 2017 in addition to posthoc analyses from the pivotal phase 3 aristotle apixaban for reduction in stroke and other thromboembolic events in atrial fibrillation trial, the bristolmyers squibb and pfizer alliance will present realworld data analyses that illustrate the alliances ongoing commitment to understanding the use of direct oral. Bleeding complications were the most commonly reported adverse events. Background apixaban, an oral factor xa inhibitor administered in fixed doses, may simplify the treatment of venous thromboembolism. Pdf apixaban for the prophylaxis and treatment of deep vein. The apixaban for reduction in stroke and other thromboembolic events in atrial fibrillation aristotle trial reported that apixaban therapy, an oral direct factor xa inhibitor, was superior to warfarin therapy in preventing stroke and allcause death while at the same time causing significantly fewer major bleeds.
Shortduration apixaban was associated with a lower frequency of stroke or systemic embolism and similar incidence of bleeds compared with heparinwarfarin. Prophylaxis of dvt following hip or knee replacement surgery. Apixaban for the acute treatment of venous thromboembolism. Emanate trial shows apixaban lowers stroke in af patients. Apixaban compared with parenteral heparin andor vitamin k. The clinical trials on this list are studying apixaban. This is a randomized, prospective, openlabel, realworld study comparing apixaban to heparin plus warfarin. The register also displays information on 18700 older paediatric trials in scope of article 45 of the paediatric regulation ec no 19012006. Study design efficacy analyses based on itt population for whom the outcome status at 6 months was documented. In the amplify clinical trial, apixaban was noninferior to warfarin plus.
The amplify ext trial is a comparison of apixaban 2. Apixaban 5mg po bid was superior to warfarin for v stroke or systemic embolism. The safea study is the first randomized controlled trial to compare 1month vs. National drug may 20 va pharmacy benefits management. In addition, it is a twicedaily oral medication that does not require routine inr or other blood level monitoring, thereby being more convenient to use compared with warfarin. Apixaban eliquis is an option for the prevention of stroke and systemic embolism in nonvalvular atrial fibrillation in accordance with its licensed indication. Download leaflet view the patient leaflet in pdf format below is a text only representation of the patient information leaflet. Averroes apixaban versus asa to prevent stroke in af patients who have failed or are unsuitable for vitamin k antagonist treatment trial n 5,599 included 1,898 patients. By inhibiting factor xa, a key blood clotting protein, eliquis decreases thrombin generation and blood clot formation. Averroes is a doubleblind, doubledummy superiority trial of apixaban 5 mg twice daily 2. Shortduration apixaban was associated with a lower frequency of stroke or systemic embolism and similar incidence of bleeds compared with. The major risk with apixaban treatment is bleeding.
These recommendations refer to transitioning patients who are taking apixaban on a long term basis and are switching to warfarin instead or if continuous, uninterrupted anticoagulation is necessary. Apr 27, 2015 apixaban is an oral anticoagulant currently approved for prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, for the treatment of deep vein thrombosis and pulmonary embolism, and for the prophylaxis of systemic embolism after orthopedic surgery. In a subgroup analysis of aristotle trial data, 743 cardioversions. Apixaban for the acute treatment of venous thromboembolism in children the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. About eliquis eliquis apixaban is an oral selective factor xa inhibitor. Listing a study does not mean it has been evaluated by the u. 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. Apixaban lowers stroke risk in atrial fibrillation. Clarification for apixaban dosing in patients with. This medicine helps to prevent blood clots from forming by blocking factor xa, which is an important component of blood clotting. Among patients with atrial fibrillation, shortduration apixaban 48 hours is feasible compared with shortduration heparinwarfarin.
Pdf apixaban for the prophylaxis and treatment of deep. The trial demonstrated that apixaban is superior in preventing thromboembolic strokes in patients with atrial fibrillation when compared to warfarin hr 0. Eliquis 5 mg filmcoated tablets patient information. Apixaban eliquis is a new direct oral factor xa inhibitor. Apixaban eliquis for stroke prevention in atrial fibrillation. The intended duration of administration of the study drug was 12 months. Clinical trial results are important because they can help doctors consider and choose the right treatment for you based on their efficacy and safety results. In aristotle, 18,201 patients with a mean chads2 score of 2. Apixaban and dalteparin in active malignancyassociated venous thromboembolism. Apixaban lowers stroke risk in atrial fibrillation patients. During the course of the trial, dual antiplatelet therapy, aspirin at a dose higher than 165 mg daily, and potent inhibitors of cytochrome p450 3a4 and pglycoprotein were prohibited. Oral apixaban for the treatment of venous thromboembolism.
The primary efficacy end point in all three trials was all vteallcause death, which was a. The amplify trial compared apixaban with enoxaparin followed by warfarin for the treatment of acute venous thromboembolism vte. Eliquis apixaban for deep vein thrombosis prophylaxis after knee replacement surgery. Apixaban 5 mg twice daily and clinical outcomes in patients. Apixaban is a highly selective, reversible inhibitor of factor xa with ki of 0. Clinical trials look at new ways to prevent, detect, or treat disease. The primary efficacy endpoint of recurrent vte or death related to vte occurred in 59 of 2609 patients 2. The study, which was presented at the european society. Rates of bleeding were similar between the two groups. There may be a similar risk associated with other doacs. In the aristotle trial, there were significantly fewer major bleeding events in patients on apixaban compared to warfarin 2.
Eliquis is approved for multiple indications in the u. Eliquis is a prescription medicine indicated to reduce the risk of stroke and. I would like to know if anyone else on eliquis has experienced the following while on this med. The new engl and journal of medicine 800 n engl j med 369. I have had a 12 pound weight gain in three months, a cough that wont go away. Engage aftimi 48 clinical trial savaysa edoxaban hcp. Efficacy and safety of apixaban compared with aspirin in the. This randomized, noninferiority trial was conducted at 358 centres in 28 countries. Apixaban for reduction in stroke and other thromboembolic. Proved apixaban was more effective compared to enoxaparin for dvt prophylaxis following knee replacement surgery. Do not stop taking your apixaban unless told by your doctor. Use of apixaban prior to cardioversion reduces risk of.
The primary objective of the trial was to determine if apixaban was superior to asa. A clinical trial has shown an increased risk of recurrent thrombotic events associated with rivaroxaban compared with warfarin, in patients with antiphospholipid syndrome and a history of thrombosis. Contains nonbinding recommendations draft guidance on apixaban recommended jun 20. Followup lasted 60 days after the final dose of study medication. According to the results of the emanate trial, patients with atrial fibrillation af who receive apixaban eliquis, bristolmyers squibbpfizer before undergoing elective cardioversion of patients with atrial fibrillation to normal sinus rhythm have a lower risk of stroke than those who receive heparin or warfarin prior to cardioversion. Apixaban 5 mg twice daily and clinical outcomes in. If eliquis is discontinued for a reason other than pathological bleeding or completion of a course of therapy.
The original leaflet can be viewed using the link above. Amplify clinical trial in amplify, eliquis apixaban demonstrated comparable efficacy with significantly fewer major bleeding events vs. Also, the 1500patient openlabel emanate trial supports an accelerated cardioversion schedule in which the procedure can be performed as soon as 2 hours after the start of bolusdosed apixaban. Also, the 1500patient openlabel emanate trial supports an accelerated cardioversion schedule in which the procedure can be performed as soon as 2. Apixaban and dalteparin in active malignancyassociated venous. Apr 15, 2014 apixaban eliquis is the third new oral anticoagulant recently labeled to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. We compared the baseline characteristics and effects of apixaban compared with aspirin on clinical outcomes by age. Apixaban, an oral factor xa inhibitor that can be administered in a simple, fixeddose regimen, may be an option for the extended treatment of venous thromboembolism. The amplify trial looked at apixaban for treatment of deep venous thrombosispulmonary embolism and excluded patients with a serum creatinine level of 2. The amplifyext trial is a comparison of apixaban 2. Revised may 2017 this draft guidance, when finalized, will represent the current thinking of the food and drug. Apixaban i f you are in an accident, or become very ill.
Clinical trials using apixaban national cancer institute. Methods in this randomized, doubleblind study, we compared apixa. Apixaban patient medication guide anticoagulation services. Key features of the expanse clinical program for apixaban in the. The new england journal of medicine 700 n engl j med 368. Ncis basic information about clinical trials explains the types and phases of trials and how they are carried out. Effectiveness and safety of apixaban versus warfarin as outpatient. Prophylaxis of dvt following hip or knee replacement. In addition, there was a significant reduction in the risk of bleeding in patients treated with apixiban compared to warfarin. Use of apixaban prior to cardioversion reduces risk of stroke. Oral apixaban for the treatment of venous thromboembolism in.
1222 507 53 182 863 885 1391 1380 53 1208 358 1355 1264 1118 278 1130 192 360 323 991 1035 920 781 1311 1297 147 465 693 436 734 512 521 1352 535 582 725 766 934 1257 153 1034 1472 117 198 678