Clinical Study Synopsis
|
|
- Miranda Ramsey
- 5 years ago
- Views:
Transcription
1 Clinical Study Synopsis This Clinical Study Synopsis is provided for patients and healthcare professionals to increase the transparency of Bayer's clinical research. This document is not intended to replace the advice of a healthcare professional and should not be considered as a recommendation. Patients should always seek medical advice before making any decisions on their treatment. Healthcare Professionals should always refer to the specific labelling information approved for the patient's country or region. Data in this document or on the related website should not be considered as prescribing advice. The study listed may include approved and non-approved formulations or treatment regimens. Data may differ from published or presented data and are a reflection of the limited information provided here. The results from a single trial need to be considered in the context of the totality of the available clinical research results for a drug. The results from a single study may not reflect the overall results for a drug. The following information is the property of Bayer HealthCare. Reproduction of all or part of this report is strictly prohibited without prior written permission from Bayer HealthCare. Commercial use of the information is only possible with the written permission of the proprietor and is subject to a license fee. Please note that the General Conditions of Use and the Privacy Statement of bayerhealthcare.com apply to the contents of this file.
2 15914 Page: 1 Date of study report: 07 MAR 2016 Study title: XANTUS - Xarelto on prevention of stroke and non-central nervous system systemic embolism in patients with non-valvular atrial fibrillation: A non-interventional study Sponsor s study (XA1101) number: NCT number: NCT EudraCT number: Not applicable Sponsor: Bayer HealthCare AG, Leverkusen, Germany Clinical phase: Phase IV, Non-interventional study Study objectives: To validate the safety profile of rivaroxaban for stroke prevention in nonvalvular atrial fibrillation (NVAF) in routine clinical practice use. To estimate incidences of treatment-emergent safety events like major bleeding, adverse events (AEs), serious AEs (SAEs) and all-cause mortality. Test drug: Rivaroxaban ( Xarelto, BAY ) Name of active Rivaroxaban, BAY ingredient(s): Anatomical Therapeutic Chemical Code: B01AF01 Dose: Xarelto 15 mg film-coated tablets; Xarelto 20 mg film-coated tablets Due to the non-interventional study design, the dose was at the discretion of the attending investigator Route of oral administration: Duration of treatment: Due to the non-interventional study design, the duration of treatment was at the discretion of the attending investigator Reference drug: Not applicable Indication: Prevention of stroke and non-central nervous system systemic embolism in non-valvular atrial fibrillation (NVAF)
3 15914 Page: 2 Diagnosis and main Consenting female and male patients 18 years of age with a diagnosis of criteria for inclusion: NVAF who start treatment with rivaroxaban for the prevention of stroke or non-cns (Central Nervous System) systemic embolism. Study design: Prospective, international, multi-center, non-interventional, observational cohort study. Post-authorization safety study. Methodology: Patients were followed up for 1 year or until 30 days after end of rivaroxaban therapy in case of earlier permanent discontinuation The visit schedule was at the discretion of the attending investigator, however it was advised to documented patients status every 3 months. Outcome measures were collected as adverse events and included major bleeding, all-cause mortality and thromboembolic events Bleeding events, cause of death, stroke events, transient ischemic attacks (TIA), non-cns systemic embolism (SE) and myocardial infarction (MI) were centrally adjudicated Haemorrhagic strokes were recorded as both, stroke and intracranial bleeding. Haemorrhagic transformations of ischaemic stroke were also reported as intracranial haemorrhage. Study center(s): 308 sites in 21 countries: Austria (11), Belgium (8), Canada (18), Czech Republic (11), Denmark (8), France (63), Germany (53), Hungary (4), Ireland (1), Israel (4), Moldova (4), The Netherlands (23), Norway (3), Poland (10), Portugal (4), Russia (32), Slovakia (15), Slovenia (4), Sweden (11), Ukraine (9), United Kingdom (12) A. John Camm et.al. XANTUS: a real-world, prospective, observational Publication(s) based on study of patients treated with rivaroxaban for stroke prevention in atrial the study fibrillation, European Heart Journal, doi: /eurheartj/ehv466 (references): Study period: Study Start Date: 12 JUN 2012 (FPFV) Study Completion Date: 31 MAR 2015 (DB clean) Early termination: no Number of subjects: Planned: 6000 Analyzed: 6784
4 15914 Page: 3 Criteria for evaluation All clinical outcomes were collected as adverse events. Statistical methods: Primary Outcome Measures: Adjudicated major bleeding events defined as overt bleeding associated with: o o o o a fall in haemoglobin (Hb) of 2 g/dl, or a transfusion of 2 units of packed red blood cells (RBCs) or whole blood, or occurrence at a critical site (intra-cranial, intra-spinal, intraocular, pericardial, intra-articular, intra-muscular with compartment syndrome, retroperitoneal), or death. AEs and SAEs. All-cause mortality Secondary Outcome Measures included: Adjudicated symptomatic stroke, TIA, SE, MI Non-major bleeding, defined as all bleeding events that do not fall in the category of major bleedings Persistence with rivaroxaban treatment, Reasons for any switch from or interruption of rivaroxaban AEs were coded using MedDRA version 17.0 based on investigator reports. For adjudicated events including major bleeding and stroke the central adjudication committee was involved in the final determination of the coded preferred term (PT). Statistical analyses were explorative and descriptive. Generally, summary tables were presented as either frequency tables or summary statistics. The main analysis population was the safety analysis set which contained all patients who took at least one dose of rivaroxaban. An AE was considered as treatment-emergent when it started on or after the day of the first dose of rivaroxaban and up to 2 days after the last dose. There were no substantial changes to the study protocol after the start of Substantial protocol changes: data collection. The latest protocol is dated 25 MAR 2015.
5 15914 Page: 4 Subject disposition and baseline Centers were requested to document each patient with NVAF treated to prevent stroke and systemic embolism in an anonymous patient log file regardless of the prescribed treatment. This led to patients being screened patients were enrolled in the study. Of these, one patient was not valid for the safety analysis set because the subject did not take rivaroxaban, leaving 6784 patients evaluable in the safety analysis set. Demographics: Rivaroxaban (N = 6784) Age (years): mean ± SD 71.5 ± 10.0 Median (Q1 Q3) 72.0 ( ) Age >75, n (%) 2524 (37.2) Age 75, n (%) 2809 (41.4) Creatinine clearance, n (%) <15 ml/min 20 (0.3) 15 <30 ml/min 75 (1.1) 30 <50 ml/min 545 (8.0) ml/min 2354 (34.7) >80 ml/min 1458 (21.5) Missing 2332 (34.4) Co-morbidities, n (%) Hypertension 5065 (74.7) Diabetes mellitus 1333 (19.6) Prior stroke/non-cns SE/TIA 1291 (19.0) Congestive HF 1265 (18.6) Prior MI 688 (10.1)
6 15914 Page: 5 Rivaroxaban (N = 6784) Mean CHADS2 score ± SD 2.0 ± 1.3 Mean CHA2DS2-VASc score ± SD 3.4 ± 1.7 Mean HAS-BLED score ± SD 2.0 ± 1.0 Treatment duration: The median (range) duration of treatment was 366 (1 802) days. The mean (SD) duration of treatment 329 (115) days Outcomes: Rivaroxaban (N = 6784) Incidence proportion, n (%) Incidence rate, events per 100 patient years Adjudicated major bleeding 128 (1.9) 2.1 ( ) Fatal* 12 (0.2) 0.2 ( ) Critical organ bleeding 43 (0.6) 0.7 ( ) Intracranial haemorrhage 26 (0.4) 0.4 ( ) Haemoglobin decrease 2 g/dl 52 (0.8) 0.9 ( ) Transfusion of 2 units of packed red blood cells or whole 53 (0.8) 0.9 ( )
7 15914 Page: 6 blood Non-major bleeding 878 (12.9) 15.4 ( ) All-cause death 118 (1.7) 1.9 ( ) Adverse events 2709 (39.9%) 57.3 ( ) Serious adverse events 1200 (17.7%) 21.4 ( ) Adjudicated thromboembolic events (stroke, SE, TIA, and 108 (1.6) 1.8 ( ) MI) Stroke/SE 51 (0.8) 0.8 ( ) Stroke 43 (0.6) 0.7 ( ) Primary haemorrhagic 11 (0.2) Primary ischaemic 32 (0.5) Haemorrhagic transformation 3 (<0.05) No haemorrhagic transformation 29 (0.4) SE 8 (0.1) 0.1 ( ) TIA 32 (0.5) 0.5 ( ) MI 27 (0.4) 0.4 ( ) Investigator reported thromboembolic events
8 15914 Page: 7 Investigator- reported deep vein thrombosis 5 (0.1%) 0.1 ( ) Investigator- reported deep pulmonary embolism 2 (0.0%) 0.0 ( ) Investigator- reported left atrial thrombus 6 (0.1%) 0.1 ( ) *Death within 30 days after treatment-emergent adjudicated major bleeding and adjudicated cause of death is bleeding Outcomes by stroke risk factors: By CHADS2 score Score, n n (%) (%) Stroke/SE, Major bleeding, All-cause death, (10.4) 0.0 ( ) 0.5 ( ) 0.2 ( ) (30.4) 0.5 ( ) 1.1 ( ) 1.2 ( ) (30.0) 0.6 ( ) 2.7 ( ) 1.9 ( ) (16.4) 1.1 ( ) 2.9 ( ) 2.9 ( ) (9.1) 2.1 ( ) 2.8 ( ) 2.6 ( ) (3.3) 3.0 ( ) 5.4 ( ) 7.3 ( ) 6 34 (0.5) 0.0 ( ) 0.0 ( ) 3.1 ( ) By CHA2DS2-VASc score Score, n n (%) (%) Stroke/SE, Major bleeding, All-cause death, (2.6) 0.0 ( ) 0.7 ( ) 0 ( ) (10.1) 0.0 ( ) 0.3 ( ) 0.2 ( ) (19.4) 0.7 ( ) 1.1 ( ) 1.4 ( )
9 15914 Page: (23.3) 0.7 ( ) 2.1 ( ) 1.7 ( ) (20.7) 0.6 ( ) 3.0 ( ) 2.0 ( ) (12.3) 1.1 ( ) 2.0 ( ) 2.6 ( ) (11.6) 2.4 ( ) 4.1 ( ) 4.3 ( ) Treatment persistence: 5418 patients (79.9%) remained persistent on treatment at 1 year after study start Adverse event pattern: AEs were broadly distributed throughout several system organ classes. The review of AEs did not reveal any particular cluster of non-bleeding events, in particular serious and/or unexpected ones. The AEs with highest incidence were epistaxis (296 patients, 4.4%), dizziness (157 patients, 2.3%), and atrial fibrillation (126 patients, 1.9%). Overall conclusions The incidence rates of and patterns of (serious) adverse events, major and non-major bleeding and thromboembolic events did not indicate a higher than expected safety risk of rivaroxaban therapy in this indication. Death was reported in 1.7% of patients, consistent with the age and underlying conditions of this population. In conclusion, this non-interventional safety study data do not give rise to any new or unexpected safety concerns.
10 Appendix to Clinical Study Synopsis Product Identification Information Product Type US Brand/Trade Name(s) Brand/Trade Name(s) ex-us Generic Name Main Product Company Code Drug Xarelto Xarelto rivaroxaban BAY Other Company Code(s) Chemical Description Other Product Aliases IUPAC Name: 5-Chloro-N-({(5S)-2-oxo-3-[4-(3-oxo-4- morpholinyl)phenyl]-1,3-oxazolidin-5-yl}methyl)-2- thiophenecarboxamide Date of last Update/Change: 04 Mar 2013
Clinical Study Synopsis
Clinical Study Synopsis This Clinical Study Synopsis is provided for patients and healthcare professionals to increase the transparency of Bayer's clinical research. This document is not intended to replace
More informationClinical Study Synopsis
Clinical Study Synopsis This Clinical Study Synopsis is provided for patients and healthcare professionals to increase the transparency of Bayer's clinical research. This document is not intended to replace
More informationClinical Study Synopsis
Clinical Study Synopsis This Clinical Study Synopsis is provided for patients and healthcare professionals to increase the transparency of Bayer's clinical research. This document is not intended to replace
More informationClinical Study Synopsis
Clinical Study Synopsis This Clinical Study Synopsis is provided for patients and healthcare professionals to increase the transparency of Bayer's clinical research. This document is not intended to replace
More informationClinical Study Synopsis
Clinical Study Synopsis This Clinical Study Synopsis is provided for patients and healthcare professionals to increase the transparency of Bayer's clinical research. This document is not intended to replace
More informationClinical Study Synopsis
Clinical Study Synopsis This Clinical Study Synopsis is provided for patients and healthcare professionals to increase the transparency of Bayer's clinical research. This document is not intended to replace
More informationClinical Study Synopsis
Clinical Study Synopsis This Clinical Study Synopsis is provided for patients and healthcare professionals to increase the transparency of Bayer's clinical research. This document is not intended to replace
More informationClinical Study Synopsis
Clinical Study Synopsis This Clinical Study Synopsis is provided for patients and healthcare professionals to increase the transparency of Bayer's clinical research. This document is not intended to replace
More informationKenneth W. Mahaffey, MD and Keith AA Fox, MB ChB
Once-daily oral direct factor Xa inhibition Compared with vitamin K antagonism for prevention of stroke and Embolism Trial in Atrial Fibrillation Kenneth W. Mahaffey, MD and Keith AA Fox, MB ChB on behalf
More informationClinical Study Synopsis
Clinical Study Synopsis This Clinical Study Synopsis is provided for patients and healthcare professionals to increase the transparency of Bayer's clinical research. This document is not intended to replace
More informationClinical Study Synopsis
Clinical Study Synopsis This Clinical Study Synopsis is provided for patients and healthcare professionals to increase the transparency of Bayer's clinical research. This document is not intended to replace
More informationGSK Medicine: Study Number: Title: Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment: Objectives:
The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.
More informationClinical Study Synopsis
Clinical Study Synopsis This Clinical Study Synopsis is provided for patients and healthcare professionals to increase the transparency of Bayer's clinical research. This document is not intended to replace
More informationClinical Study Synopsis
Clinical Study Synopsis This file is posted on the Bayer HealthCare Clinical Trials Registry and Results website or on the website www.clinicalstudyresults.org hosted by the Pharmaceutical Research and
More informationClinical Study Synopsis
Clinical Study Synopsis This Clinical Study Synopsis is provided for patients and healthcare professionals to increase the transparency of Bayer's clinical research. This document is not intended to replace
More informationClinical Study Synopsis
Clinical Study Synopsis This file is posted on the Bayer HealthCare Clinical Trials Registry and Results website or on the website www.clinicalstudyresults.org hosted by the Pharmaceutical Research and
More informationClinical Study Synopsis
Clinical Study Synopsis This Clinical Study Synopsis is provided for patients and healthcare professionals to increase the transparency of Bayer's clinical research. This document is not intended to replace
More informationClinical Study Synopsis
Clinical Study Synopsis This Clinical Study Synopsis is provided for patients and healthcare professionals to increase the transparency of Bayer's clinical research. This document is not intended to replace
More informationClinical Study Synopsis
Clinical Study Synopsis This Clinical Study Synopsis is provided for patients and healthcare professionals to increase the transparency of Bayer's clinical research. This document is not intended to replace
More informationClinical Study Synopsis
Clinical Study Synopsis This Clinical Study Synopsis is provided for patients and healthcare professionals to increase the transparency of Bayer's clinical research. This document is not intended to replace
More informationClinical Study Synopsis
Clinical Study Synopsis This Clinical Study Synopsis is provided for patients and healthcare professionals to increase the transparency of Bayer's clinical research. This document is not intended to replace
More informationClinical Trial Study Synopsis
Clinical Trial Study Synopsis This file is posted on the Bayer HealthCare Clinical Trials Registry and Results website and is provided for patients and healthcare professionals to increase the transparency
More informationClinical Study Synopsis
Clinical Study Synopsis This Clinical Study Synopsis is provided for patients and healthcare professionals to increase the transparency of Bayer's clinical research. This document is not intended to replace
More informationClinical Study Synopsis
Clinical Study Synopsis This Clinical Study Synopsis is provided for patients and healthcare professionals to increase the transparency of Bayer's clinical research. This document is not intended to replace
More informationReal World Evidence on the Use of NOACs
Real World Evidence on the Use of NOACs Prof. Fausto J. Pinto, MD, PhD, FESC, FACC ESC President Head, Cardiology Dpt/University Hospital Sta Maria-HPV University of Lisbon, Portugal RIYHAD, 12 H FEBRUARY
More informationClinical Study Synopsis
Clinical Study Synopsis This file is posted on the Bayer HealthCare Clinical Trials Registry and Results website or on the website www.clinicalstudyresults.org hosted by the Pharmaceutical Research and
More informationClinical Study Synopsis
Clinical Study Synopsis This Clinical Study Synopsis is provided for patients and healthcare professionals to increase the transparency of Bayer's clinical research. This document is not intended to replace
More informationClinical Study Synopsis
Clinical Study Synopsis This Clinical Study Synopsis is provided for patients and healthcare professionals to increase the transparency of Bayer's clinical research. This document is not intended to replace
More informationClinical Study Synopsis
Clinical Study Synopsis This Clinical Study Synopsis is provided for patients and healthcare professionals to increase the transparency of Bayer's clinical research. This document is not intended to replace
More informationClinical Study Synopsis
Clinical Study Synopsis This Clinical Study Synopsis is provided for patients and healthcare professionals to increase the transparency of Bayer's clinical research. This document is not intended to replace
More informationClinical Study Synopsis
Clinical Study Synopsis This document is not intended to replace the advice of a healthcare professional and should not be considered as a recommendation. Patients should always seek medical advice before
More informationClinical Study Synopsis
Clinical Study Synopsis This document is not intended to replace the advice of a healthcare professional and should not be considered as a recommendation. Patients should always seek medical advice before
More informationClinical Study Synopsis
Clinical Study Synopsis This document is not intended to replace the advice of a healthcare professional and should not be considered as a recommendation. Patients should always seek medical advice before
More informationClinical Study Synopsis
Clinical Study Synopsis This document is not intended to replace the advice of a healthcare professional and should not be considered as a recommendation. Patients should always seek medical advice before
More informationClinical Study Synopsis
Clinical Study Synopsis This Clinical Study Synopsis is provided for patients and healthcare professionals to increase the transparency of Bayer's clinical research. This document is not intended to replace
More informationClinical Study Synopsis
Clinical Study Synopsis This document is not intended to replace the advice of a healthcare professional and should not be considered as a recommendation. Patients should always seek medical advice before
More informationARTEMIS. ARixtra (fondaparinux) for ThromboEmbolism prevention in. a Medical Indications Study. NV Organon Protocol 63129
ARTEMIS ARixtra (fondaparinux) for ThromboEmbolism prevention in NV Organon Protocol 63129 a Medical Indications Study Objective To demonstrate efficacy and to assess safety of oncedaily subcutaneous (SC)
More informationClinical Study Synopsis
Clinical Study Synopsis This document is not intended to replace the advice of a healthcare professional and should not be considered as a recommendation. Patients should always seek medical advice before
More informationClinical Study Synopsis
Clinical Study Synopsis This document is not intended to replace the advice of a healthcare professional and should not be considered as a recommendation. Patients should always seek medical advice before
More informationClinical Study Synopsis
Clinical Study Synopsis This document is not intended to replace the advice of a healthcare professional and should not be considered as a recommendation. Patients should always seek medical advice before
More informationAfter acute coronary syndromes patients continue to have recurrent ischemic events despite revascularization and dual antiplatelet therapy
Randomised Dabigatran Etexilate Dose Finding Study In Patients With Acute Coronary Syndromes Post Index Event With Additional Risk Factors For Cardiovascular Complications Also Receiving Aspirin and Clopidogrel
More informationWebposting Clinical Trial Results Synopsis
Study Summary This summary information is provided for patients and healthcare professionals to increase the transparency of Bayer's clinical research. This summary information is not intended to replace
More informationIndividual Therapeutic Selection Of Anti-coagulants And Periprocedural. Miguel Valderrábano, MD
Individual Therapeutic Selection Of Anti-coagulants And Periprocedural Management Miguel Valderrábano, MD Outline Does the patient need anticoagulation? Review of clinical evidence for each anticoagulant
More informationClinical Study Synopsis
Clinical Study Synopsis This Clinical Study Synopsis is provided for patients and healthcare professionals to increase the transparency of Bayer's clinical research. This document is not intended to replace
More informationClinical Study Synopsis
Clinical Study Synopsis This Clinical Study Synopsis is provided for patients and healthcare professionals to increase the transparency of Bayer's clinical research. This document is not intended to replace
More informationState of art in anticoagulation in non valvular Atrial Fibrillation: the additional value of Rivaroxaban real life data
State of art in anticoagulation in non valvular Atrial Fibrillation: the additional value of Rivaroxaban real life data Massimo Grimaldi Ospedale F. Miulli Acquaviva delle Fonti - Bari Disclosure Biosense
More informationClinical Trial Study Synopsis
Clinical Trial Study Synopsis This file is posted on the Bayer HealthCare Clinical Trials Registry and Results website and is provided for patients and healthcare professionals to increase the transparency
More informationDisclosure. Financial disclosure: National Advisory Board & Research Grant from Boehringer-Ingelheim
Randomised Dabigatran Etexilate Dose Finding Study In Patients With Acute Coronary Syndromes Post Index Event With Additional Risk Factors For Cardiovascular Complications Also Receiving Aspirin and Clopidogrel
More informationClinical Study Synopsis
Clinical Study Synopsis This Clinical Study Synopsis is provided for patients and healthcare professionals to increase the transparency of Bayer's clinical research. This document is not intended to replace
More informationPrimary Care Prescriber Information RIVAROXABAN (XARELTO ) Prevention of stroke and embolism for nonvalvular atrial fibrillation
Primary Care Prescriber Information RIVAROXABAN (XARELTO ) Prevention of stroke and embolism for nonvalvular atrial fibrillation INDICATION Rivaroxaban is a non-vitamin K antagonist oral anticoagulant
More informationClinical Study Synopsis
Clinical Study Synopsis This document is not intended to replace the advice of a healthcare professional and should not be considered as a recommendation. Patients should always seek medical advice before
More informationClinical Study Synopsis
Clinical Study Synopsis This Clinical Study Synopsis is provided for patients and healthcare professionals to increase the transparency of Bayer's clinical research. This document is not intended to replace
More informationClinical Trial Study Synopsis
Clinical Trial Study Synopsis This file is posted on the Bayer HealthCare Clinical Trials Registry and Results website and is provided for patients and healthcare professionals to increase the transparency
More informationLatest News and Clinical Applications of NOACs: What about Antidotes?
Optimizing outcomes in Atrial Fibrillation Latest News and Clinical Applications of NOACs: What about Antidotes? McMaster Cardiology Update September 11, 2015 Agenda Real world data on the use of NOACs
More informationNew Data Reaffirm Positive Benefit-Risk Balance of Bayer s Xarelto in Patients with Atrial Fibrillation in Daily Clinical Practice
Investor News Not intended for U.S. and UK Media Bayer AG Investor Relations 51368 Leverkusen Germany www.investor.bayer.com 12 th Annual Congress of the European Cardiac Arrhythmia Society (ECAS) 2016:
More informationOn behalf of the RE-CIRCUIT Investigators. March 19, :45 am 10:55 am. Johns Hopkins Medical Institutions, Baltimore, MD, USA.
Safety and Efficacy of Uninterrupted Anticoagulation with Dabigatran Etexilate versus in Patients Undergoing Catheter Ablation of Atrial Fibrillation: The RE-CIRCUIT Study Hugh Calkins, M.D., 1 Stephan
More informationRETROSPECTIVE CLAIMS DATABASE STUDIES OF DIRECT ORAL ANTICOAGULANTS (DOACS) FOR STROKE PREVENTION IN NONVALVULAR ATRIAL FIBRILLATION
RETROSPECTIVE CLAIMS DATABASE STUDIES OF DIRECT ORAL ANTICOAGULANTS (DOACS) FOR STROKE PREVENTION IN NONVALVULAR ATRIAL FIBRILLATION Craig I. Coleman, PharmD Professor, University of Connecticut School
More informationClinical Study Synopsis
Clinical Study Synopsis This Clinical Study Synopsis is provided for patients and healthcare professionals to increase the transparency of Bayer's clinical research. This document is not intended to replace
More informationClinical Study Synopsis
Clinical Study Synopsis This document is not intended to replace the advice of a healthcare professional and should not be considered as a recommendation. Patients should always seek medical advice before
More informationPIONEER AF-PCI Study with Bayer s Xarelto Accepted as Late- Breaking Clinical Trial Presentation at AHA 2016
News Release Not intended for U.S. and UK Media Bayer AG Communications, Government Relations & Corporate Brand 51368 Leverkusen Germany Tel. +49 214 30-0 www.news.bayer.com American Heart Association
More informationAtrial Fibrillaiton and Heart Failure: Anticoagulation therapy in all cases?
Atrial Fibrillaiton and Heart Failure: Anticoagulation therapy in all cases? Nicolas Lellouche Fédération de Cardiologie Hôpital Henri Mondor Créteil Disclosure Statement of Financial Interest I currently
More informationEdoxaban. Edoxaban for preventing stroke and systemic embolism in people with non-valvular atrial fibrillation
Edoxaban Edoxaban for preventing stroke and systemic embolism in people with non-valvular atrial fibrillation NICE approved the reproduction of its content for this booklet. NICE is independent of any
More informationRivaroxaban 10 mg Once Daily from Bayer Submitted to U.S. FDA as Additional Dose Option to Reduce the Risk of Recurrent Venous Thromboembolism
Investor News Not intended for U.S. and UK Media Bayer AG Investor Relations 51368 Leverkusen Germany www.investor.bayer.com Rivaroxaban 10 mg Once Daily from Bayer Submitted to U.S. FDA as Additional
More informationClinical Study Synopsis
Clinical Study Synopsis This Clinical Study Synopsis is provided for patients and healthcare professionals to increase the transparency of Bayer's clinical research. This document is not intended to replace
More informationClinical Study Synopsis
Clinical Study Synopsis This Clinical Study Synopsis is provided for patients and healthcare professionals to increase the transparency of Bayer's clinical research. This document is not intended to replace
More informationGuidance for management of bleeding in patients taking the new oral anticoagulant drugs: rivaroxaban, dabigatran or apixaban
Guidance for management of bleeding in patients taking the new oral anticoagulant drugs: rivaroxaban, dabigatran or apixaban Purpose The aim of this guidance is to outline the management of patients presenting
More informationHEALTH PROFESSIONAL V BAYER
CASE AUTH/3035/4/18 HEALTH PROFESSIONAL V BAYER Promotion of Xarelto An anonymous complainant who described him/herself as a concerned UK health professional complained about an Xarelto (rivaroxaban) advertisement
More informationTechnology appraisal guidance Published: 23 May 2012 nice.org.uk/guidance/ta256
Rivaroxaban for the prevention ention of stroke and systemic embolism in people with atrial fibrillation Technology appraisal guidance Published: 23 May 2012 nice.org.uk/guidance/ta256 NICE 2018. All rights
More informationNew Study Presented at American Heart Association (AHA) Scientific Sessions 2016:
Investor News Not intended for U.S. and UK Media Bayer AG Investor Relations 51368 Leverkusen Germany www.investor.bayer.com New Study Presented at American Heart Association (AHA) Scientific Sessions
More informationOn behalf of the RE-CIRCUIT Investigators. March 19, :45 am 10:55 am. Johns Hopkins Medical Institutions, Baltimore, MD, USA.
Safety and Efficacy of Uninterrupted Anticoagulation with Dabigatran Etexilate versus Warfarin in Patients Undergoing Catheter Ablation of Atrial Fibrillation: The RE-CIRCUIT Study Hugh Calkins, M.D.,
More informationClinical Study Synopsis
Clinical Study Synopsis This document is not intended to replace the advice of a healthcare professional and should not be considered as a recommendation. Patients should always seek medical advice before
More informationA Patient Unsuitable for VKA Treatment
Will Apixaban change practice in atrial fibrillation? A Patient Unsuitable for VKA Treatment Professor Yoseph Rozenman The E. Wolfson Medical Center Jerusalem June 2013 Disclosures I have the following
More informationBayer submits application for marketing approval of rivaroxaban for patients with coronary or peripheral artery disease to European Medicines Agency
Investor News Not intended for U.S. and UK Media Bayer AG Investor Relations 51368 Leverkusen Germany www.investor.bayer.com Bayer submits application for marketing approval of rivaroxaban for patients
More informationAmerican College of Cardiology 66th Annual Scientific Session (ACC.17):
News Release Not intended for U.S. and UK Media Bayer AG Communications and Public Affairs 51368 Leverkusen Germany Tel. +49 214 30-0 www.news.bayer.com American College of Cardiology 66th Annual Scientific
More informationAnticoagulation Therapy in LTC
Anticoagulation Therapy in LTC By: Cynthia Leung, RPh, BScPhm, PharmD. Clinical Consultant Pharmacist MediSystem Pharmacy Jun 11, 2013 Agenda Stroke and Bleeding Risk Assessment Review of Oral Anticoagulation
More informationApixaban for Atrial Fibrillation in Patients with End-Stage Renal Disease on Dialysis
Apixaban for Atrial Fibrillation in Patients with End-Stage Renal Disease on Dialysis Caitlin Reedholm, PharmD PGY1 Pharmacy Resident St. David s South Austin Medical Center November 2, 2018 Abbreviations
More informationOnline Supplementary Data. Country Number of centers Number of patients randomized
A Randomized, Double-Blind, -Controlled, Phase-2B Study to Evaluate the Safety and Efficacy of Recombinant Human Soluble Thrombomodulin, ART-123, in Patients with Sepsis and Suspected Disseminated Intravascular
More informationResults from RE-LY and RELY-ABLE
Results from RE-LY and RELY-ABLE Assessment of the safety and efficacy of dabigatran etexilate (Pradaxa ) in longterm stroke prevention EXECUTIVE SUMMARY Dabigatran etexilate (Pradaxa ) has shown a consistent
More informationPros and Cons of Individual Agents Based on Large Trial Results: RELY, ROCKET, ARISTOTLE, AVERROES
Pros and Cons of Individual Agents Based on Large Trial Results: RELY, ROCKET, ARISTOTLE, AVERROES Ralph L. Sacco, MS MD FAAN FAHA Olemberg Family Chair in Neurological Disorders Miller Professor of Neurology,
More informationHERTFORDSHIRE MEDICINES MANAGEMENT COMMITTEE (HMMC) DABIGATRAN RECOMMENDED What it is Indications Date decision last revised
Name: generic (trade) Dabigatran etexilate (Pradaxa ) HERTFORDSHIRE MEDICINES MANAGEMENT COMMITTEE (HMMC) DABIGATRAN RECOMMENDED What it is Indications Date decision last revised Direct thrombin inhibitor
More informationBayer s Rivaroxaban Demonstrated Superior Protection Against Recurrent Venous Thromboembolism Compared with Aspirin in EINSTEIN CHOICE Study
News Release Not intended for U.S. and UK Media Bayer AG Communications and Public Affairs 51368 Leverkusen Germany Tel. +49 214 30-0 www.news.bayer.com New Late-Breaking Study Data Presented at ACC.17:
More informationNEW/NOVEL ORAL ANTICOAGULANTS (NOACS): COMPARISON AND FREQUENTLY ASKED QUESTIONS
NEW/NOVEL ORAL ANTICOAGULANTS (NOACS): COMPARISON AND FREQUENTLY ASKED QUESTIONS OBJECTIVES: To provide a comparison of the new/novel oral anticoagulants (NOACs) currently available in Canada. To address
More informationNOACs Update PD Dr. Jan Steffel Leitender Arzt, Klinik für Kardiologie Co-Leiter Rhythmologie Universitätsspital Zürich
NOACs Update 2016 PD Dr. Jan Steffel Leitender Arzt, Klinik für Kardiologie Co-Leiter Rhythmologie Universitätsspital Zürich Conflict of Interest Statement o o o o Consulting: Amgen, Astra Zeneca, AtriCure,
More informationInvestor Conference Call
Investor Conference Call Data from the Phase III COMPASS trial, A Randomized Controlled Trial of Rivaroxaban for the Prevention of Major Cardiovascular Events in Patients With Coronary or Peripheral Artery
More informationSupplementary Appendix
Supplementary Appendix This appendix has been provided by the authors to give readers additional information about their work. Supplement to: Eikelboom JW, Connolly SJ, Brueckmann M, et al. versus warfarin
More informationRivaroxaban film coated tablets are available in 2 strengths for this indication: 15mg and 20mg.
Primary Care Prescriber Information RIVAROXABAN (XARELTO ) Treatment of acute venous thromboembolism and prevention of recurrent venous thromboembolism INDICATION Rivaroxaban is a non-vitamin K antagonist
More informationMedical Policy An independent licensee of the Blue Cross Blue Shield Association
Oral Anticoagulants Page 1 of 7 Medical Policy An independent licensee of the Blue Cross Blue Shield Association Title: Oral Anticoagulant - Bevyxxa (betrixaban), Eliquis (apixaban), Pradaxa (dabigatran),
More informationAn international, double-blind, phase III randomized trial. Main Results
An international, double-blind, phase III randomized trial Main Results Robert Hart on behalf of the NAVIGATE ESUS Steering Committee and Investigators Sponsorship & Disclosures NAVIGATE ESUS was sponsored
More informationClinical Study Synopsis
Clinical Study Synopsis This document is not intended to replace the advice of a healthcare professional and should not be considered as a recommendation. Patients should always seek medical advice before
More informationPARALLELISM AND THE LEGITIMACY GAP 1. Appendix A. Country Information
PARALLELISM AND THE LEGITIMACY GAP 1 Appendix A Country Information PARALLELISM AND THE LEGITIMACY GAP 2 Table A.1 Sample size by country 2006 2008 2010 Austria 2405 2255 0 Belgium 1798 1760 1704 Bulgaria
More informationSupplemental New Drug Application for Rivaroxaban to reduce the risk of stent thrombosis in patients with Acute Coronary Syndrome also resubmitted
Investor News Not intended for U.S. and UK Media Bayer AG Investor Relations 51368 Leverkusen Germany www.investor.bayer.com Complete Response Submitted to U.S. FDA on Bayer s Rivaroxaban for the Reduction
More informationDrug Class Review Newer Oral Anticoagulant Drugs
Drug Class Review Newer Oral Anticoagulant Drugs Final Original Report May 2016 The purpose of reports is to make available information regarding the comparative clinical effectiveness and harms of different
More informationPrimary Care Prescriber Information EDOXABAN (LIXIANA ) Prevention of stroke and embolism for nonvalvular atrial fibrillation
Primary Care Prescriber Information EDOXABAN (LIXIANA ) Prevention of stroke and embolism for nonvalvular atrial fibrillation INDICATION Edoxaban is a non-vitamin K antagonist oral anticoagulant (NOAC)
More informationICSS Safety Results NOT for PUBLICATION. June 2009 ICSS ICSS ICSS ICSS. International Carotid Stenting Study: Main Inclusion Criteria
Safety Results NOT for The following slides were presented to the Investigators Meeting on 22/05/09 and most of them were also presented at the European Stroke Conference on 27/05/09 They are NOT for in
More informationPCI in Patients with AF Optimizing Oral Anticoagulation Regimen
PCI in Patients with AF Optimizing Oral Anticoagulation Regimen Walid I. Saliba, MD Director, Atrial Fibrillation Center Heart and Vascular Institute Cleveland Clinic 1 Epidemiology and AF and PCI AF and
More informationBayer AG Investor Relations Leverkusen Germany Investor News. Not intended for U.S. and UK Media
Investor News Not intended for U.S. and UK Media Bayer AG Investor Relations 51368 Leverkusen Germany www.investor.bayer.com Bayer Initiates Xarelto (Rivaroxaban) Study in Patients with Non- Valvular Atrial
More informationBayer s rivaroxaban submitted to U.S. FDA for approval in patients with coronary and/or peripheral artery disease
Investor News Not intended for U.S. and UK Media Bayer AG Investor Relations 51368 Leverkusen Germany www.investor.bayer.com Bayer s rivaroxaban submitted to U.S. FDA for approval in patients with coronary
More informationClinical Study Synopsis
Clinical Study Synopsis This Clinical Study Synopsis is provided for patients and healthcare professionals to increase the transparency of Bayer's clinical research. This document is not intended to replace
More informationAims. AF and Stroke risk Guidance re anticoagulation Novel oral anticoagulants (NOACs) in non-valvular AF (NVAF) Practical Issues Patient Case Studies
Aims AF and Stroke risk Guidance re anticoagulation Novel oral anticoagulants (NOACs) in non-valvular AF (NVAF) Practical Issues Patient Case Studies AF and Stroke AF prevalence approx doubles with each
More information