Edoxaban Management in Diagnostic and Therapeutic Procedures

Completed

• Conditions: Atrial Fibrillation; Venous Thromboembolism
• Interventions: Procedure: Edoxaban

• Registration Number: NCT02950168
• Lead Sponsor: Daiichi Sankyo

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2016-10-28
• Study First Submitted QC: 2016-10-28
• Study First Posted: 2016-10-31
• Study Start: 2016-11
• Primary Completion: 2018-07-26
• Study Completion: 2018-07-26
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-03
• Last Update Posted: 2020-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1197

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Edoxaban	Edoxaban	All patients treated with edoxaban with a planned or unplanned diagnostic or interventional procedure

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Percentage of participants with acute coronary syndromes within 30 days after a planned or unplanned procedure	within 30 days after a 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