Edoxaban Management in Diagnostic and Therapeutic Procedures

NCT02950168 | Completed

• 1 other identifier: DSE-EDO-02-15-EU
• Study Type: observational
• Target: 1,197
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Atrial Fibrillation; Venous Thromboembolism

Keywords

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

Outcome Measures

Primary Outcomes (2)

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

  within 30 days after a procedure

• 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 Outcomes (1)

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

  within 30 days after a procedure

Other Outcomes (1)

• Number of procedures undergone by trial participants by type

  within the 2.5 year study

Study Arms (1)

Edoxaban

All patients treated with edoxaban with a planned or unplanned diagnostic or interventional procedure

Procedure: Edoxaban

Interventions

Edoxaban PROCEDURE

Edoxaban according to Summary of Product Characteristic (SMPC)

Also known as: Lixiana

Edoxaban

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Edoxaban-treated patients with NVAF, VAT or PE undergoing planned or unplanned diagnostic or interventional procedures

You may qualify if:

• 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)

You may not qualify if:

• None

Sponsors & Collaborators

• Daiichi Sankyo: lead

Related Publications (6)

• 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.

  PMID: 24251359 BACKGROUND

• 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.

  PMID: 31492505 RESULT

• Unverdorben M, Colonna P, Jin J, Kohler S, Santamaria A, Saxena M, Borrow A, Chen C, von Heymann C, Vanassche T. Periprocedural Edoxaban Management and Clinical Outcomes in Patients Undergoing Transcatheter Cardiovascular Procedures in the EMIT-AF/VTE Program. Clin Appl Thromb Hemost. 2024 Jan-Dec;30:10760296241260728. doi: 10.1177/10760296241260728.

  PMID: 38881370 DERIVED

• von Heymann C, Unverdorben M, Colonna P, Santamaria A, Saxena M, Vanassche T, Kohler S, Borrow AP, Jin J, Chen C. Management of edoxaban therapy and clinical outcomes in patients undergoing major or nonmajor surgery: a subanalysis of the EMIT-AF/VTE study. Thromb J. 2023 Dec 14;21(1):124. doi: 10.1186/s12959-023-00568-2.

  PMID: 38098072 DERIVED

• Santamaria A, Chen C, Colonna P, von Heymann C, Saxena M, Vanassche T, Jin J, Unverdorben M. Predictive Factors and Clinical Events Associated with Edoxaban Interruption and Heparin Bridging Strategy: EMIT-AF/VTE. Clin Appl Thromb Hemost. 2023 Jan-Dec;29:10760296231200223. doi: 10.1177/10760296231200223.

  PMID: 37697813 DERIVED

• 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.

  PMID: 33256590 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation; Venous Thromboembolism

Interventions

edoxaban

Condition Hierarchy (Ancestors)

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

Study Officials

• Global Clinical Leader

  Daiichi Sankyo

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2016
• First Posted: October 31, 2016
• Study Start: November 1, 2016
• Primary Completion: July 26, 2018
• Study Completion: July 26, 2018
• Last Updated: February 5, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
• Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.