ProjectEncourage-AF-PCI – EEdoxaban in patients with Non-valvular atrial fibrillation undergoing perCutaneOUs coRonAry…

Basic data

Acronym:
Encourage-AF-PCI
Title:
EEdoxaban in patients with Non-valvular atrial fibrillation undergoing perCutaneOUs coRonAry intervention – a GErman non-interventional study
Duration:
12/17/2020 to 12/31/2023
Abstract / short description:
Rationale:
In order to better understand the edoxaban usage in the German real-world clinical setting in patients with NVAF undergoing PCI, Daiichi-Sankyo Germany wants to perform this NIS to gain insights into the current treatment of these patients. The treatment patterns and the extent of exposure of edoxaban and other antiplatelet therapy will be investigated. Furthermore, safety data will be collected.
Real world evidence data of routine clinical usage of relevant concomitant medication and quality of life (QoL) data (if available) up to 1 year will be collected and evaluated in 1200 patients, treated by specialized physicians in German hospitals.
Study Design:
A German, multicenter, prospective, non-interventional, non-comparative study. The patient recruitment is planned for 18 months or longer, if required. The observation period of the study starts 4 hours to 72 hours after removal of the guiding catheter of successful PCI and ends one year post procedure.
Objectives:
To to gain insights in real-world clinical data on the peri- and post-procedural usage of anticoagulation and antiplatelet therapy in patients with NVAF undergoing successful PCI treated with edoxaban.
Secondary Objectives:
o To describe the safety of edoxaban in combination with antiplatelet therapy in patients with NVAF after successful PCI in real life setting
o To describe the effectiveness of edoxaban in combination with antiplatelet therapy in patients with NVAF after successful PCI in real life setting
o To describe the QoL of patients treated with edoxaban in combination with antiplatelet therapy in patients with NVAF after successful PCI in real life setting
Subgroup analyses (e.g. per region) may be performed in predefined patient populations for primary and secondary objectives.

Involved staff

Managers

Department of Internal Medicine
Hospitals and clinical institutes, Faculty of Medicine

Contact persons

Faculty of Medicine
University of Tübingen

Local organizational units

Internal Medicine Department III
Department of Internal Medicine
Hospitals and clinical institutes, Faculty of Medicine

Funders

München, Bayern, Germany
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