Design and rationale of the Edoxaban Treatment in routiNe clinical prActice for patients with Atrial Fibrillation in Europe (ETNA-AF-Europe) study

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 A...
Source: Journal of Cardiovascular Medicine - Category: Cardiology Tags: Research articles: Trial design Source Type: research

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AbstractThe best strategy in atrial fibrillation (AF) after  >  12 months after an acute coronary syndrome or in patients with chronic coronary syndrome without an indication for interventional revascularization remains unclear. European guidelines generally recommend therapy with oral anticoagulation (OAC) alone, whereas North American guidelines advise com bination therapy consisting of OAC plus antiplatelet therapy in some patients. We performed a meta-analysis of available trials comparing these treatment strategies. The primary endpoint was major adverse cardiac events (MACE), secondary endp...
Source: Journal of Thrombosis and Thrombolysis - Category: Hematology Source Type: research
Conclusion: In ischemic stroke or TIA patients with platelet count within normal range, platelet count may be a qualified predictor for long-term recurrent stroke, mortality, and poor functional outcome. Introduction Platelets exert a critical role in the pathogenesis of atherosclerotic complications of cardio-cerebrovascular disease, contributing to thrombus formation, and embolism (1, 2). Previous literature reported that platelets of various size and density are produced by megakaryocytes of different size and stages of maturation in different clinical conditions, suggesting various platelet patterns in differen...
Source: Frontiers in Neurology - Category: Neurology Source Type: research
ConclusionsIn older adults treated with direct-acting oral anticoagulants after ischemic stroke, outcome rates varied considerably by drug and dosage.
Source: Drugs and Aging - Category: Geriatrics Source Type: research
Conclusions—In anticoagulated patients with atrial fibrillation and risk factors for stroke, echocardiographic findings do not seem to add to the risk of thromboembolic events.Clinical Trial Registration—URL: http://www.clinicaltrials.gov. Unique identifier: NCT00412984.
Source: Stroke - Category: Neurology Authors: Tags: Arrhythmias, Echocardiography, Intracranial Hemorrhage, Ischemic Stroke Original Contributions Source Type: research
Abstract PURPOSE: The findings from the observational studies comparing the effectiveness and safety of non-vitamin K antagonist oral anticoagulants (NOACs) versus vitamin K antagonists (VKAs) for atrial fibrillation (AF) and venous thromboembolism (VTE) are inconsistent. We conducted separate meta-analyses examining the efficacy/effectiveness and safety of NOACs versus VKAs by disease (AF vs VTE), study design (randomized controlled trials [RCTs] vs observational studies), and NOAC (dabigatran, rivaroxaban, apixaban, and edoxaban). METHODS: The main data sources included PubMed/MEDLINE, EMBASE, Web of Scienc...
Source: Clinical Therapeutics - Category: Drugs & Pharmacology Authors: Tags: Clin Ther Source Type: research
Conclusion This study will provide important information regarding the effectiveness and safety of rivaroxaban treatment in Japanese patients with NVAF among general practitioners.
Source: Journal of Arrhythmia - Category: Cardiology Source Type: research
Background and Purpose— Patients with atrial fibrillation and previous ischemic stroke (IS)/transient ischemic attack (TIA) are at high risk of recurrent cerebrovascular events despite anticoagulation. In this prespecified subgroup analysis, we compared warfarin with edoxaban in patients with versus without previous IS/TIA. Methods— ENGAGE AF-TIMI 48 (Effective Anticoagulation With Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis in Myocardial Infarction 48) was a double-blind trial of 21 105 patients with atrial fibrillation randomized to warfarin (international normalized ratio, 2.0–3.0; m...
Source: Stroke - Category: Neurology Authors: Tags: Atrial Fibrillation, Anticoagulants, Ischemic Stroke Clinical Sciences Source Type: research
Conclusion In the FDA-approved cohort of the ENGAGE AF–-TIMI 48 trial, treatment with edoxaban 60/30 mg was superior to warfarin in the prevention of SSE and significantly reduced cardiovascular death and bleeding, especially fatal bleeding and hemorrhagic stroke.
Source: American Heart Journal - Category: Cardiology Source Type: research
Conclusion In this small case series, reversal of NOAC with FEIBA was not associated with ICH expansion or any thrombotic or hemorrhagic complications.
Source: Neurocritical Care - Category: Neurology Source Type: research
In conclusion, compared with warfarin, dabigatran treatment was associated with a lower risk of stroke and most outcomes measured, but increased incidence of major lower GI bleeding. PMID: 26446456 [PubMed - as supplied by publisher]
Source: Thrombosis and Haemostasis - Category: Hematology Authors: Tags: Thromb Haemost Source Type: research
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