Edoxaban Management in Diagnostic and Therapeutic Procedures

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1197 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-11-30

Study Completion Date

2018-07-26

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.

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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.

Conditions

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Atrial Fibrillation Venous Thromboembolism

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Edoxaban

All patients treated with edoxaban with a planned or unplanned diagnostic or interventional procedure

Edoxaban

Intervention Type PROCEDURE

Edoxaban according to Summary of Product Characteristic (SMPC)

Interventions

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Edoxaban

Edoxaban according to Summary of Product Characteristic (SMPC)

Intervention Type PROCEDURE

Other Intervention Names

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Lixiana

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)