Edoxaban Management in Diagnostic and Therapeutic Procedures

Study Overview
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Brief Summary
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Patients receiving Novel Oral Anticoagulation (NOACs) undergo diagnostic and therapeutic procedures at a rate of 10% per year. Short half-lives and rapid onset of action allow for short periods of NOAC interruption without heparin bridging. There is only minimal information on the peri-procedural usage pattern of edoxaban and the related outcome data currently available. Therefore, further real-world clinical data on the peri-procedural usage pattern of edoxaban within any diagnostic or interventional procedure in patients with non-valvular atrial fibrillation (NVAF) or venous thromboembolism (VTE) will be collected in this registry.

Detailed Description
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Patients treated with edoxaban and with a planned or unplanned diagnostic or interventional procedure will be enrolled in this study in order to evaluate the peri-procedural dosing of edoxaban in patients with diagnostic or therapeutic procedures and collect details of the type diagnostic or therapeutic procedures. Patients from 7 different countries and care settings (primary care, secondary care, and different medical specialties) will be enrolled. The study will last until approximately 2000 procedures have been documented, e.g., until about 2000 participants are enrolled, which is expected to take approximately 2.5 years. Any relevant diagnostic or interventional procedure reported will be collected and documented in the electronic case report form (eCRF). Patients will be followed for 30 days after the procedure.

Official Title
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Edoxaban Management in Diagnostic and Therapeutic Procedures

Conditions
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Atrial Fibrillation, Venous Thromboembolism

Intervention / Treatment
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* Procedure: Edoxaban


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients taking edoxaban for a therapeutic indication for edoxaban according to SMPC including NVAF, DVT or PE Patients with a planned or unplanned diagnostic or therapeutic procedure Written informed consent Availability of patients for follow-up by telephone by the site No concurrent participation in an interventional study (simultaneous participation in other non-interventional studies is possible) Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Edoxaban<br>All patients treated with edoxaban with a planned or unplanned diagnostic or interventional procedure | Procedure: Edoxaban<br>* Edoxaban according to Summary of Product Characteristic (SMPC)<br>* Other names: Lixiana;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants with major bleeding within 30 days after a planned or unplanned procedure |  | within 30 days after a procedure | 
| Percentage of participants with clinically-significant non-major bleeding (CRNMB) within 30 days after a planned or unplanned procedure | Categories: minor bleeding, all bleeding, and death from any cause | within 30 days after a procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants with acute coronary syndromes within 30 days after a planned or unplanned procedure | Categories: unstable angina pectoris, myocardial infarction, non-haemorrhagic stroke, transient ischaemic attack (TIA), systemic embolism (SEE), deep vein thrombosis (DVT), pulmonary embolism (PE) and cardiovascular (CV) mortality | within 30 days after a procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diagnostic procedures, Interventional procedures, Planned or unplanned, Edoxaban-treated population