Design and rationale of the Edoxaban Treatment in routiNe clinical prActice for patients with Atrial Fibrillation in Europe (ETNA-AF-Europe) study.
- De Caterina R Università degli Studi 'G. D'Annunzio', Chieti, Italy.
- Kelly P HRB Stroke Clinical Trials Network Ireland, University College Dublin, Ireland.
- Monteiro P Centro Hospitalar e Universitário de Coimbra, Portugal.
- Deharo JC Hôpital de la Timone, Marseille, France.
- de Asmundis C Universitair Ziekenhuis Brussels, Belgium.
- López-de-Sá E Hospital Universitario La Paz, IDIPAZ, Madrid, Spain.
- Weiss TW Wilhelminenhospital and Sigmund Freud University, Vienna, Austria.
- Waltenberger J University of Munster, Germany.
- Steffel J University Hospital of Zurich, Switzerland.
- de Groot JR Academic Medical Center/University of Amsterdam, The Netherlands.
- Levy P Université Paris-Dauphine, PSL Research University, Paris, France.
- Bakhai A Royal Free London NHS Foundation Trust, Chase Farm Hospital, London, UK.
- Zierhut W Daiichi Sankyo Europe GmbH, Munich, Germany.
- Laeis P Daiichi Sankyo Europe GmbH, Munich, Germany.
- Reimitz PE Daiichi Sankyo Europe GmbH, Munich, Germany.
- Kirchhof P Institute of Cardiovascular Sciences, University of Birmingham, SWBH and UHB NHS Trusts, Birmingham, UK.
- 2018-12-13
Published in:
- Journal of cardiovascular medicine (Hagerstown, Md.). - 2019
Administration, Oral
Atrial Fibrillation
Europe
Factor Xa Inhibitors
Hemorrhage
Humans
Prospective Studies
Pyridines
Registries
Research Design
Stroke
Thiazoles
Time Factors
Treatment Outcome
English
AIM
Edoxaban, a nonvitamin K antagonist oral anticoagulant, is an oral factor Xa inhibitor approved for the prevention of stroke and systemic embolism in adult patients with atrial fibrillation and for the treatment and secondary prevention in adult patients with venous thromboembolism (VTE). This study details the design of the Edoxaban Treatment in routiNe clinical prActice for patients with Atrial Fibrillation in Europe (ETNA-AF-Europe) study - a postauthorization observational study, which is part of the postapproval plan for edoxaban agreed with the European Medicines Agency.
METHODS
The ETNA-AF-Europe study (Clinicaltrials.gov: NCT02944019) is a multicenter, prospective, observational study that enrolled 13 980 patients with atrial fibrillation treated with edoxaban from 852 sites across 10 European countries (Austria, Belgium, Germany, Ireland, Italy, the Netherlands, Portugal, Spain, Switzerland, and the United Kingdom). Patients treated with edoxaban were prospectively enrolled and will be followed up for 4 years with yearly follow-up visits.
ASSESSMENTS
The primary objective of the ETNA-AF-Europe study is to assess the real-world safety of edoxaban by evaluating bleeding events, including intracranial hemorrhage; drug-related adverse events, such as hepatic events; and cardiovascular and all-cause mortality. In addition, efficacy will be assessed by recording major adverse cardiovascular events including stroke, systemic embolic events, transient ischemic attacks, and also VTE episodes, acute coronary syndromes, and hospitalizations related to cardiovascular condition. Event rates will be compared with event rates reported in the PREvention oF thromboembolic events-European Registry in Atrial Fibrillation in atrial fibrillation (PREFER in AF) and PREFER in AF Prolongation registries, and in the Effective Anticoagulation with Factor Xa Next Generation in Atrial Fibrillation - Thrombolysis in Myocardial Infarction 48 study datasets.
Edoxaban, a nonvitamin K antagonist oral anticoagulant, is an oral factor Xa inhibitor approved for the prevention of stroke and systemic embolism in adult patients with atrial fibrillation and for the treatment and secondary prevention in adult patients with venous thromboembolism (VTE). This study details the design of the Edoxaban Treatment in routiNe clinical prActice for patients with Atrial Fibrillation in Europe (ETNA-AF-Europe) study - a postauthorization observational study, which is part of the postapproval plan for edoxaban agreed with the European Medicines Agency.
METHODS
The ETNA-AF-Europe study (Clinicaltrials.gov: NCT02944019) is a multicenter, prospective, observational study that enrolled 13 980 patients with atrial fibrillation treated with edoxaban from 852 sites across 10 European countries (Austria, Belgium, Germany, Ireland, Italy, the Netherlands, Portugal, Spain, Switzerland, and the United Kingdom). Patients treated with edoxaban were prospectively enrolled and will be followed up for 4 years with yearly follow-up visits.
ASSESSMENTS
The primary objective of the ETNA-AF-Europe study is to assess the real-world safety of edoxaban by evaluating bleeding events, including intracranial hemorrhage; drug-related adverse events, such as hepatic events; and cardiovascular and all-cause mortality. In addition, efficacy will be assessed by recording major adverse cardiovascular events including stroke, systemic embolic events, transient ischemic attacks, and also VTE episodes, acute coronary syndromes, and hospitalizations related to cardiovascular condition. Event rates will be compared with event rates reported in the PREvention oF thromboembolic events-European Registry in Atrial Fibrillation in atrial fibrillation (PREFER in AF) and PREFER in AF Prolongation registries, and in the Effective Anticoagulation with Factor Xa Next Generation in Atrial Fibrillation - Thrombolysis in Myocardial Infarction 48 study datasets.
- Language
-
- English
- Open access status
- green
- Identifiers
-
- DOI 10.2459/JCM.0000000000000737
- PMID 30540648
- Persistent URL
- https://folia.unifr.ch/global/documents/260656
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