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Xarelto studies

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https://www.readbyqxmd.com/read/29657592/design-and-baseline-characteristics-of-the-xarelto-post-authorization-safety-effectiveness-study-in-japanese-patients-with-atrial-fibrillation-xapass
#1
Satoshi Ogawa, Kazuo Minematsu, Takanori Ikeda, Takanari Kitazono, Jyoji Nakagawara, Susumu Miyamoto, Yuji Murakawa, Yohei Ohashi, Makiko Takeichi, Yutaka Okayama, Satoshi Yamanaka, Lyo Inuyama
Background: The phase III Japanese Rivaroxaban Once-Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (J-ROCKET AF) showed that the rivaroxaban group had a lower event rate of intracranial bleeding than the warfarin group and that rivaroxaban was noninferior to warfarin for the principal safety outcome. However, safety and effectiveness data from unselected patients with AF in everyday clinical practice in Japan are lacking...
April 2018: Journal of Arrhythmia
https://www.readbyqxmd.com/read/29566414/understanding-the-value-of-real-world-evidence-focus-on-stroke-prevention-in-atrial-fibrillation-with-rivaroxaban
#2
A John Camm, Craig I Coleman, Torben Bjerregaard Larsen, Peter Brønnum Nielsen, Capt Sally Tamayo
Real-world data are a well-recognized component within the drug lifecycle, and such data are generated from a range of sources and study designs, including claims databases, electronic health records, non-interventional studies (NIS) and registries. While this information can be of vital clinical importance, there may be challenges in understanding the relevance of the differing study designs, endpoints and populations. Here, we summarize the value of real-world evidence and considerations pertinent to their use in clinical research...
March 22, 2018: Thrombosis and Haemostasis
https://www.readbyqxmd.com/read/29432317/the-outcomes-of-early-surgical-intervention-in-geriatric-proximal-femur-fractures-among-patients-receiving-direct-oral-anticoagulation
#3
Nathan A Franklin, Ashley Ali, Richard K Hurley, Hassan R Mir, Michael J Beltran
OBJECTIVE: Evaluate the pre-hospital use of Direct Oral Anticoagulant (DOAC) agents on the outcomes of early surgical fixation of a geriatric hip fracture. DESIGN: Case-Control. SETTING: Two academic level 1 trauma centers. INTERVENTION: Early (<48h) surgical fixation of a geriatric proximal femur fracture. PATIENTS: 19 patients receiving Pradaxa (Dabigatran), Eliquis (Apixaban), or Xarelto (Rivaroxaban) who underwent surgery between 2010 and 2015 and 74 control patients...
February 9, 2018: Journal of Orthopaedic Trauma
https://www.readbyqxmd.com/read/29345985/cyp3a-activity-and-rivaroxaban-serum-concentrations-in-russian-patients-with-deep-vein-thrombosis
#4
Dmitriy Alexeyevich Sychev, Arshak Vardanyan, Aleksandr Rozhkov, Edita Hachatryan, Ani Badanyan, Valery Smirnov, Anna Ananichuk, Natalya Denisenko
BACKGROUND: Rivaroxaban is metabolized in the liver via CYP3A4, the cytochrome involved in the metabolism of nearly 50% of all medications. Thus, its effective concentration depends on multiple pharmacologic parameters. METHODS: The primary goal of our research was to study the correlation between the CYP3A family activity and the safety and efficacy of anticoagulant therapy with rivaroxaban in patients with deep vein thrombosis (DVT). Thirty one patients with DVT aged 21-83 years, 18 men and 13 women, received rivaroxaban (Xarelto) 30 mg/day for 21 days after diagnosis and 20 mg/day for the follow-up period of 6 months...
January 2018: Genetic Testing and Molecular Biomarkers
https://www.readbyqxmd.com/read/29304263/the-prevalence-of-adverse-ocular-hemorrhagic-events-in-patients-utilizing-oral-anticoagulant-and-antiplatelet-therapy-in-routine-clinical-practice
#5
Dattanand M Sudarshana, Eleni K Konstantinou, Sruthi Arepalli, Fabiana Q Silva, Andrew P Schachat, Justis P Ehlers, Rishi P Singh
BACKGROUND AND OBJECTIVE: Previous literature assessing ocular hemorrhagic complications of anticoagulant/antiplatelet medications in routine clinical practice is limited. This study evaluates the prevalence of spontaneous ocular hemorrhagic events associated with anticoagulation/antiplatelet therapy. PATIENTS AND METHODS: A retrospective study was performed to identify patients taking anticoagulants (rivaroxaban [Xarelto; Janssen Pharmaceuticals, Beerse, Belgium], bivalirudin [Angiomax; The Medicines Company, Parsippany, NJ], lepirudin [Refludan; Bayer HealthCare Pharmaceuticals, Berlin, Germany], dabigatran [Pradaxa; Boehringer Ingelheim, Ingelheim am Rhein, Germany], and argatroban) and antiplatelet agents (clopidogrel [Plavix; Bristol-Myers Squibb, New York City, NY], prasugrel [Effient; Lilly Medical, Indianapolis, IN], and ticagrelor [Brilinta; AstraZeneca, Cambridge, UK]) who presented for an eye examination...
January 1, 2018: Ophthalmic Surgery, Lasers & Imaging Retina
https://www.readbyqxmd.com/read/28892526/rivaroxaban-vs-warfarin-sodium-in-the-ultra-early-period-after-atrial-fibrillation-related-mild-ischemic-stroke-a-randomized-clinical-trial
#6
RANDOMIZED CONTROLLED TRIAL
Keun-Sik Hong, Sun U Kwon, Sang Hun Lee, Ji Sung Lee, Yong-Jae Kim, Tae-Jin Song, Young Dae Kim, Man-Seok Park, Eung-Gyu Kim, Jae-Kwan Cha, Sang Min Sung, Byung-Woo Yoon, Oh Young Bang, Woo-Keun Seo, Yang-Ha Hwang, Seong Hwan Ahn, Dong-Wha Kang, Hyun Goo Kang, Kyung-Ho Yu
Importance: In atrial fibrillation (AF)-related acute ischemic stroke, the optimal oral anticoagulation strategy remains unclear. Objective: To test whether rivaroxaban or warfarin sodium is safer and more effective for preventing early recurrent stroke in patients with AF-related acute ischemic stroke. Design, Setting, and Participants: A randomized, multicenter, open-label, blinded end point evaluation, comparative phase 2 trial was conducted from April 28, 2014, to December 7, 2015, at 14 academic medical centers in South Korea among patients with mild AF-related stroke within the previous 5 days who were deemed suitable for early anticoagulation...
October 1, 2017: JAMA Neurology
https://www.readbyqxmd.com/read/28674871/real-life-use-of-rivaroxaban-in-the-netherlands-data-from-the-xarelto-for-prevention-of-stroke-in-patients-with-atrial-fibrillation-xantus-registry
#7
R Pisters, S P G van Vugt, M A Brouwer, A Elvan, W L Ten Holt, P A G Zwart, P Kirchhof, H J G M Crijns, M E W Hemels
BACKGROUND: The Xarelto for Prevention of Stroke in Patients with Atrial Fibrillation (XANTUS) registry investigated the safety and efficacy of the factor Xa inhibitor rivaroxaban. We studied the Dutch XANTUS cohort to a ssess drug safety and prescription patterns in the Netherlands. METHODS: The XANTUS registry was designed as a European prospective, observational study among patients with non-valvular atrial fibrillation. Major bleeding and all-cause mortality were assessed every three months during a 1-year follow-up period...
October 2017: Netherlands Heart Journal
https://www.readbyqxmd.com/read/28625215/assessing-coagulation-by-rotational-thromboelastometry-rotem-in-rivaroxaban-anticoagulated-blood-using-hemostatic-agents
#8
Jonathan Bar, Alexa David, Tarek Khader, Mary Mulcare, Christopher Tedeschi
Introduction The use of direct oral anticoagulants (DOACs) such as rivaroxaban (Xarelto) is increasingly common. However, therapies for reversing anticoagulation in the event of hemorrhage are limited. This study investigates the ability of hemostatic agents to improve the coagulation of rivaroxaban-anticoagulated blood, as measured by rotational thromboelastometry (ROTEM). Hypothesis/Problem If a chitosan-based hemostatic agent (Celox), which works independently of the clotting cascade, is applied to rivaroxaban-anticoagulated blood, it should improve coagulation by decreasing clotting time (CT), decreasing clot formation time (CFT), and increasing maximum clot firmness (MCF)...
October 2017: Prehospital and Disaster Medicine
https://www.readbyqxmd.com/read/28395685/the-benefit-of-pharmacological-venous-thromboprophylaxis-in-foot-and-ankle-surgery
#9
N P Saragas, P N F Ferrao, B F Jacobson, E Saragas, A Strydom
BACKGROUND: Ten percent of patients with a deep-vein thrombosis (DVT) will develop a fatal pulmonary embolism (PE), often initially asymptomatic. The risks and benefits of pharmacological thromboprophylaxis are well documented in respect of total joint arthroplasty and hip fractures, but little is understood about the incidence of venous thromboembolism (VTE) or the potential risks and benefits of chemoprophylaxis in foot and ankle surgery. OBJECTIVE: To determine whether prophylactic chemoprophylaxis had any impact on the prevention of VTE in a cohort of foot and ankle surgical patients requiring the combination of below-knee cast immobilisation and non-weightbearing for ≥4 weeks...
March 29, 2017: South African Medical Journal, Suid-Afrikaanse Tydskrif Vir Geneeskunde
https://www.readbyqxmd.com/read/27623681/rivaroxaban-real-world-evidence-validating-safety-and-effectiveness-in-clinical-practice
#10
Jan Beyer-Westendorf, A John Camm, Craig I Coleman, Sally Tamayo
Randomised controlled trials (RCTs) are considered the gold standard of clinical research as they use rigorous methodologies, detailed protocols, pre-specified statistical analyses and well-defined patient cohorts. However, RCTs do not take into account the complexity of real-world clinical decision-making. To tackle this, real-world data are being increasingly used to evaluate the long-term safety and effectiveness of a given therapy in routine clinical practice and in patients who may not be represented in RCTs, addressing key clinical questions that may remain...
September 28, 2016: Thrombosis and Haemostasis
https://www.readbyqxmd.com/read/27455072/does-anticoagulant-medication-alter-fracture-healing-a-morphological-and-biomechanical-evaluation-of-the-possible-effects-of-rivaroxaban-and-enoxaparin-using-a-rat-closed-fracture-model
#11
Peter Michael Prodinger, Rainer Burgkart, Kilian Kreutzer, Franz Liska, Hakan Pilge, Andreas Schmitt, Martina Knödler, Boris Michael Holzapfel, Alexander Hapfelmeier, Thomas Tischer, Oliver Bissinger
Low molecular weight heparin (LMWH) is routinely used to prevent thromboembolism in orthopaedic surgery, especially in the treatment of fractures or after joint-replacement. Impairment of fracture-healing due to increased bone-desorption, delayed remodelling and lower calcification caused by direct osteoclast stimulation is a well-known side effect of unfractioned heparin. However, the effect of LMWH is unclear and controversial. Recent studies strongly suggest impairment of bone-healing in-vitro and in animal models, characterized by a significant decrease in volume and quality of new-formed callus...
2016: PloS One
https://www.readbyqxmd.com/read/27362695/impact-of-switching-from-a-vitamin-k-antagonist-to-rivaroxaban-on-satisfaction-with-anticoagulation-therapy-the-xantus-acts-substudy
#12
MULTICENTER STUDY
Craig I Coleman, Sylvia Haas, Alexander G G Turpie, Silvia Kuhls, Susanne Hess, Thomas Evers, Pierre Amarenco, Paulus Kirchhof, A John Camm
BACKGROUND: The efficacy, safety, and ease of use of rivaroxaban may reduce anticoagulation-treatment burden and improve nonvalvular atrial fibrillation (NVAF) patient satisfaction compared with vitamin K antagonists (VKAs). HYPOTHESIS: Transitioning from a VKA to rivaroxaban improves treatment satisfaction in routine practice. METHODS: Xarelto for Prevention of Stroke in Patients With Atrial Fibrillation (XANTUS) is a prospective, noninterventional study in patients with NVAF prescribed rivaroxaban for prevention of stroke in routine practice...
October 2016: Clinical Cardiology
https://www.readbyqxmd.com/read/27313435/a-pilot-study-comparing-hospital-readmission-rates-in-patients-receiving-rivaroxaban-or-enoxaparin-after-orthopedic-surgery
#13
Melissa A Herschman, Frank S Rigelsky, Sandra S Axtell
PURPOSE: A pilot study was conducted to determine whether rivaroxaban (Xarelto, Janssen Pharmaceuticals) resulted in a lower 30-day all-cause readmission rate compared with enoxaparin (Lovenox, Sanofi-Aventis) after total hip arthroplasty (THA) or total knee arthroplasty (TKA) at a community hospital. METHODS: The study was a single-center, retrospective, chart-review investigation involving patients who underwent THA or TKA between May 2013 and May 2014. The study's primary endpoint was the 30-day all-cause readmission rate...
June 2016: P & T: a Peer-reviewed Journal for Formulary Management
https://www.readbyqxmd.com/read/27112188/clinical-and-economic-impact-of-rivaroxaban-on-the-burden-of-atrial-fibrillation-the-case-study-of-japan
#14
Masatsugu Hori, Shunya Ikeda, Ken Okumura, Shinya Matsuda, Yukihiro Koretsune, Calypso Montouchet, Emi Watanabe-Fujinuma, Thomas Evers, Bruno Rossi, Lewis Ruff, Jean-Baptiste Briere
OBJECTIVES: Atrial fibrillation (AF) affects an estimated 1.5 million individuals in Japan, increasing their stroke risk and imposing considerable costs on the Japanese healthcare system. To reduce stroke incidence, guidelines recommend using anticoagulants in moderate-to-high risk non-valvular AF (NVAF) patients; however, many patients receive no treatment, aspirin only, or remain poorly-controlled on vitamin K antagonists (VKAs) due to high VKA discontinuation rates and non-adherence to guidelines...
September 2016: Journal of Medical Economics
https://www.readbyqxmd.com/read/27013144/novel-oral-anticoagulants-in-plastic-surgery
#15
REVIEW
C F Munson, A J Reid
Novel oral anticoagulants (NOACs) have emerged as a good alternative to warfarin in the prevention of stroke for patients with atrial fibrillation. NOAC use is increasing rapidly; therefore, greater understanding of their use in the perioperative period is important for optimal care. Studies and reviews that reported on the use of NOACs were identified, with particular focus on the perioperative period. PubMed was searched for relevant articles published between January 2000 and August 2015. The inevitable rise in the use of NOACs such as rivaroxaban (Xarelto™), apixaban (Eliquis™), edoxaban (Lixiana™) and dabigatran (Pradaxa™) may present a simplified approach to perioperative anticoagulant management due to fewer drug interactions, rapidity of onset of action and relatively short half-lives...
May 2016: Journal of Plastic, Reconstructive & Aesthetic Surgery: JPRAS
https://www.readbyqxmd.com/read/26408640/rivaroxaban-for-thromboprophylaxis-after-fracture-related-orthopedic-surgery-in-routine-clinical-practice
#16
MULTICENTER STUDY
Michael R Lassen, Sylvia Haas, Reinhold Kreutz, Lorenzo G Mantovani, Gerlind Holberg, Alexander G G Turpie
BACKGROUND: The risk of venous thromboembolism is high in patients undergoing fracture-related major orthopedic surgery, but data on pharmacological thromboprophylaxis are limited. This analysis evaluated the effectiveness and safety of rivaroxaban after fracture-related orthopedic surgery in routine care compared with other pharmacological thromboprophylaxis (standard of care [SOC]). METHODS: The study population comprised a subset of patients with lower-limb fracture from XArelto in the prophylaxis of post-surgical venous thromboembolism after elective Major Orthopaedic Surgery of hip or knee (XAMOS; a phase IV noninterventional study) and a XAMOS extension study (XAMOS-Extra)...
March 2016: Clinical and Applied Thrombosis/hemostasis
https://www.readbyqxmd.com/read/26298448/an-observational-study-of-the-factor-xa-inhibitors-rivaroxaban-and-apixaban-as-reported-to-eight-poison-centers
#17
Henry A Spiller, James B Mowry, Alfred Aleguas, Jill R K Griffith, Robert Goetz, Mark L Ryan, Stacey Bangh, Wendy Klein-Schwartz, Scott Schaeffer, Marcel J Casavant
STUDY OBJECTIVE: Rivaroxaban and apixaban are part of a new group of oral anticoagulants targeting factor Xa and approved by the Food and Drug Administration in 2011 and 2012. These oral anticoagulants are administered at fixed daily doses, without the need for laboratory-guided adjustments. There are limited data available on supratherapeutic doses or overdose of the oral Xa inhibitors. This study characterizes the clinical effect in patients exposed to rivaroxaban and apixaban. METHODS: A retrospective study collected data from 8 regional poison centers covering 9 states...
February 2016: Annals of Emergency Medicine
https://www.readbyqxmd.com/read/26095540/direct-acting-oral-anticoagulants-pharmacology-indications-management-and-future-perspectives
#18
REVIEW
Antonio Gómez-Outes, Ma Luisa Suárez-Gea, Ramón Lecumberri, Ana Isabel Terleira-Fernández, Emilio Vargas-Castrillón
In recent years, several direct-acting oral anticoagulants (DOAC) have become available for use in Europe and other regions in indications related to prophylaxis and treatment of venous and arterial thromboembolism. They include the oral direct thrombin inhibitor dabigatran etexilate (Pradaxa, Boehringer Ingelheim) and the oral direct FXa inhibitors rivaroxaban (Xarelto, Bayer HealthCare), apixaban (Eliquis, Bristol-Myers Squibb), and edoxaban (Lixiana/Savaysa, Daiichi-Sankyo). The new compounds have a predictable dose response and few drug-drug interactions (unlike vitamin k antagonists), and they do not require parenteral administration (unlike heparins)...
November 2015: European Journal of Haematology
https://www.readbyqxmd.com/read/25973138/real-world-data-confirm-clinical-trial-outcomes-for-rivaroxaban-in-orthopaedic-patients
#19
REVIEW
Louis Kwong, Alexander G G Turpie
Venous thromboembolism (VTE) is a potential cause of morbidity and mortality in patients after major orthopaedic surgery. Based on the results of the international phase III RECORD (Regulation of Coagulation in Orthopaedic Surgery to Prevent Deep Vein Thrombosis and Pulmonary Embolism) program, the oral, direct Factor Xa inhibitor rivaroxaban has been approved in many countries for the prevention of VTE after elective hip arthroplasty or knee arthroplasty. However, study results of randomized controlled trials may have limited generalizability to routine clinical practice in unselected patients...
May 2015: Current Orthopaedic Practice
https://www.readbyqxmd.com/read/25819852/rationale-and-design-of-a-study-exploring-the-efficacy-of-once-daily-oral-rivaroxaban-x-tra-on-the-outcome-of-left-atrial-left-atrial-appendage-thrombus-in-nonvalvular-atrial-fibrillation-or-atrial-flutter-and-a-retrospective-observational-registry-providing
#20
RANDOMIZED CONTROLLED TRIAL
Gregory Y H Lip, Christoph Hammerstingl, Francisco Marin, Riccardo Cappato, Isabelle Ling Meng, Bodo Kirsch, Eolo Morandi, Martin van Eickels, Ariel Cohen
There are still many unresolved issues concerning patient outcomes and prognostic factors in patients with atrial fibrillation (AF) and left atrial/left atrial appendage (LA/LAA) thrombi. Rivaroxaban (Xarelto®), a potent and highly selective oral, direct factor Xa inhibitor, is a new therapeutic option in this setting. The planned study program will consist of a prospective interventional study (X-TRA) and a retrospective observational registry (CLOT-AF). The primary objective of the X-TRA study is to explore the efficacy of rivaroxaban in the treatment of LA/LAA thrombi in patients with nonvalvular AF or atrial flutter, scheduled to undergo cardioversion or AF ablation, in whom an LA/LAA thrombus has been found on transesophageal echocardiography (TEE) before the procedure...
April 2015: American Heart Journal
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