Edoxaban Management in Diagnostic and Therapeutic Procedures (EMIT-AF/VTE)

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ClinicalTrials.gov Identifier: NCT02950168

Recruitment Status : Completed

First Posted : October 31, 2016

Last Update Posted : February 5, 2020

Sponsor:

Information provided by (Responsible Party):

Daiichi Sankyo, Inc.

Study Description

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.

Condition or disease	Intervention/treatment
Atrial Fibrillation Venous Thromboembolism	Procedure: Edoxaban

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.

Study Design

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Study Type :	Observational [Patient Registry]
Actual Enrollment :	1197 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Target Follow-Up Duration:	30 Days
Official Title:	Edoxaban Management in Diagnostic and Therapeutic Procedures
Study Start Date :	November 2016
Actual Primary Completion Date :	July 26, 2018
Actual Study Completion Date :	July 26, 2018

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Familial atrial fibrillation

Drug Information available for: Edoxaban

U.S. FDA Resources

Groups and Cohorts

Group/Cohort	Intervention/treatment
Edoxaban All patients treated with edoxaban with a planned or unplanned diagnostic or interventional procedure	Procedure: Edoxaban Edoxaban according to Summary of Product Characteristic (SMPC) Other Name: Lixiana

Outcome Measures

Primary Outcome Measures :

Percentage of participants with major bleeding within 30 days after a planned or unplanned procedure [ Time Frame: 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 [ Time Frame: within 30 days after a procedure ]
Categories: minor bleeding, all bleeding, and death from any cause

Secondary Outcome Measures :

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 Outcome Measures:

Number of procedures undergone by trial participants by type [ Time Frame: within the 2.5 year study ]
Categories: Planned and Unplanned

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

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

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02950168

Sponsors and Collaborators

Daiichi Sankyo, Inc.

Investigators

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Study Director:	Global Clinical Leader	Daiichi Sankyo, Inc.

More Information

Additional Information:

Publications of Results:

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.

Other Publications:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Erratum in: BMC Cardiovasc Disord. 2021 Feb 15;21(1):91.

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Responsible Party:	Daiichi Sankyo, Inc.
ClinicalTrials.gov Identifier:	NCT02950168
Other Study ID Numbers:	DSE-EDO-02-15-EU
First Posted:	October 31, 2016 Key Record Dates
Last Update Posted:	February 5, 2020
Last Verified:	February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Yes
Plan Description:	De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Supporting Materials:	Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (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.
URL:	https://vivli.org/ourmember/daiichi-sankyo/

Keywords provided by Daiichi Sankyo, Inc.:


Diagnostic procedures Interventional procedures Planned or unplanned Edoxaban-treated population

Additional relevant MeSH terms:

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Atrial Fibrillation Thromboembolism Venous Thromboembolism Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes Embolism and Thrombosis Vascular Diseases	Edoxaban Factor Xa Inhibitors Antithrombins Serine Proteinase Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anticoagulants

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