Clinical trial NCT02950168: Edoxaban Management in Diagnostic and Therapeutic Procedures
Official title: Edoxaban Management in Diagnostic and Therapeutic Procedures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Venous Thromboembolism
Keywords: Diagnostic procedures
Interventional procedures
Planned or unplanned
Edoxaban-treated population
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2016-10-31
Enrollment: 1197
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Edoxaban-treated patients with NVAF, VAT or PE undergoing planned or unplanned diagnostic or interventional procedures

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of participants with major bleeding within 30 days after a planned or unplanned procedure
timeFrame: within 30 days after a procedure
measure: Percentage of participants with clinically-significant non-major bleeding (CRNMB) within 30 days after a planned or unplanned procedure
timeFrame: within 30 days after a procedure
Secondary outcomes:
measure: Percentage of participants with acute coronary syndromes within 30 days after a planned or unplanned procedure
timeFrame: within 30 days after a procedure
Other outcomes:
measure: Number of procedures undergone by trial participants by type
timeFrame: within the 2.5 year study
Locations:
Study officials:
affiliation: Daiichi Sankyo
name: Global Clinical Leader
role: STUDY_DIRECTOR
References:
citation: Giugliano RP, Ruff CT, Braunwald E, Murphy SA, Wiviott SD, Halperin JL, Waldo AL, Ezekowitz MD, Weitz JI, Spinar 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.
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 after successful coronary stenting in patients with atrial fibrillation (ENTRUST-AF PCI): a randomised, open-label, phase 3b trial. Lancet. 2019 Oct 12;394(10206):1335-1343. doi: 10.1016/S0140-6736(19)31872-0. Epub 2019 Sep 3.
citation: Unverdorben M, von Heymann C, Santamaria A, Saxena M, Vanassche T, Jin J, Laeis P, Wilkins R, Chen C, Colonna P. Elderly patients with atrial fibrillation in routine clinical practice-peri-procedural management of edoxaban oral anticoagulation therapy is associated with a low risk of bleeding and thromboembolic complications: a subset analysis of the prospective, observational, multinational EMIT-AF study. BMC Cardiovasc Disord. 2020 Dec 1;20(1):504. doi: 10.1186/s12872-020-01766-w.