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

Group/Cohort | Intervention/treatment |
---|---|
Edoxaban
All patients treated with edoxaban with a planned or unplanned diagnostic or interventional procedure
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Procedure: Edoxaban
Edoxaban according to Summary of Product Characteristic (SMPC)
Other Name: Lixiana |
- 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
- 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
- Number of procedures undergone by trial participants by type [ Time Frame: within the 2.5 year study ]Categories: Planned and Unplanned

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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 |
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

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
Study Director: | Global Clinical Leader | Daiichi Sankyo, Inc. |
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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/ |
Diagnostic procedures Interventional procedures Planned or unplanned Edoxaban-treated population |
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 |