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OpenTrials
Completed

NCT Number: NCT02950168

Edoxaban Management in Diagnostic and Therapeutic Procedures

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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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Embolism and Thrombosis Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Thromboembolism Vascular Diseases Venous Thromboembolism

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Edoxaban

Procedure

Edoxaban according to Summary of Product Characteristic (SMPC)

Other names: Lixiana

Primary outcomes

  1. Percentage of participants with major bleeding within 30 days after a planned or unplanned procedure

    Time frame: within 30 days after a procedure

  2. Percentage of participants with clinically-significant non-major bleeding (CRNMB) within 30 days after a planned or unplanned procedure

    Time frame: within 30 days after a procedure

    Categories: minor bleeding, all bleeding, and death from any cause

Secondary outcomes

  1. Percentage of participants with acute coronary syndromes within 30 days after a planned or unplanned procedure

    Time frame: 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

Other outcomes

  1. Number of procedures undergone by trial participants by type

    Time frame: within the 2.5 year study

    Categories: Planned and Unplanned

Sponsors and collaborators

Lead sponsor

Daiichi Sankyo

Industry

Registry information

Acronym: EMIT-AF/VTE

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Oct 31, 2016
Registry last updated
Feb 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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