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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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.

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.

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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

Drug Information available for: Edoxaban

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




Primary Outcome Measures :
  1. Percentage of participants with major bleeding within 30 days after a planned or unplanned procedure [ Time Frame: within 30 days after a procedure ]
  2. 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 :
  1. 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:
  1. Number of procedures undergone by trial participants by type [ Time Frame: within the 2.5 year study ]
    Categories: Planned and Unplanned



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

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.

Additional Information:

Publications of Results:
Other Publications:
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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