Encourage-AF-PCI

EEdoxaban in patients with Non-valvular atrial fibrillation undergoing perCutaneOUs coRonAry intervention – a GErman non-interventional study

17.12.2020 bis 31.12.2023

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.