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Edoxaban Management in Diagnostic and Therapeutic Procedures

Edoxaban Management in Diagnostic and Therapeutic Procedures

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02950168
Acronym
EMIT-AF/VTE
Enrollment
1197
Registered
2016-10-31
Start date
2016-11-30
Completion date
2018-07-26
Last updated
2020-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Venous Thromboembolism

Keywords

Diagnostic procedures, Interventional procedures, Planned or unplanned, Edoxaban-treated population

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.

Interventions

PROCEDUREEdoxaban

Edoxaban according to Summary of Product Characteristic (SMPC)

Sponsors

Daiichi Sankyo
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Percentage of participants with major bleeding within 30 days after a planned or unplanned procedurewithin 30 days after a procedure
Percentage of participants with clinically-significant non-major bleeding (CRNMB) within 30 days after a planned or unplanned procedurewithin 30 days after a procedureCategories: minor bleeding, all bleeding, and death from any cause

Secondary

MeasureTime frameDescription
Percentage of participants with acute coronary syndromes within 30 days after a planned or unplanned procedurewithin 30 days after a procedureCategories: 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

MeasureTime frameDescription
Number of procedures undergone by trial participants by typewithin the 2.5 year studyCategories: Planned and Unplanned

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026