Edoxaban Management in Diagnostic and Therapeutic Procedures

Atrial Fibrillation Clinical Trial

— EMIT-AF/VTE  

Official title:

Edoxaban Management in Diagnostic and Therapeutic Procedures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02950168
• Other study ID #: DSE-EDO-02-15-EU
• Status: Completed
• Start date: November 2016
• Est. completion date: July 26, 2018

Study information

• Verified date: February 2020
• Source: Daiichi Sankyo, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1197
• Est. completion date: July 26, 2018
• Est. primary completion date: July 26, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Thromboembolism
• Venous Thromboembolism

Intervention

Procedure:
• Edoxaban
Edoxaban according to Summary of Product Characteristic (SMPC)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Daiichi Sankyo, Inc.

References & Publications (2)

Giugliano RP, Ruff CT, Braunwald E, Murphy SA, Wiviott SD, Halperin JL, Waldo AL, Ezekowitz MD, Weitz JI, Špinar J, Ruzyllo W, Ruda M, Koretsune Y, Betcher J, Shi M, Grip LT, Patel SP, Patel I, Hanyok JJ, Mercuri M, Antman EM; ENGAGE AF-TIMI 48 Investigators. Edoxaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2013 Nov 28;369(22):2093-104. doi: 10.1056/NEJMoa1310907. Epub 2013 Nov 19. — View Citation

Vranckx P, Valgimigli M, Eckardt L, Tijssen J, Lewalter T, Gargiulo G, Batushkin V, Campo G, Lysak Z, Vakaliuk I, Milewski K, Laeis P, Reimitz PE, Smolnik R, Zierhut W, Goette A. Edoxaban-based versus vitamin K antagonist-based antithrombotic regimen afte — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of procedures undergone by trial participants by type	Categories: Planned and Unplanned	within the 2.5 year study
Primary	Percentage of participants with major bleeding within 30 days after a planned or unplanned procedure		within 30 days after a procedure
Primary	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	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