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History of Changes for Study: NCT02950168
Edoxaban Management in Diagnostic and Therapeutic Procedures (EMIT-AF/VTE)
Latest version (submitted February 3, 2020) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 October 28, 2016 None (earliest Version on record)
2 October 20, 2017 Recruitment Status, Study Status, Contacts/Locations, Oversight and Sponsor/Collaborators
3 November 28, 2017 Study Status
4 January 2, 2018 Study Status
5 September 13, 2018 Recruitment Status, Study Status and Study Design
6 December 20, 2018 IPDSharing and Study Status
7 February 3, 2020 Study Status and References
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Study NCT02950168
Submitted Date:  October 28, 2016 (v1)

Open or close this module Study Identification
Unique Protocol ID: DSE-EDO-02-15-EU
Brief Title: Edoxaban Management in Diagnostic and Therapeutic Procedures (EMIT-AF/VTE)
Official Title: Edoxaban Management in Diagnostic and Therapeutic Procedures
Secondary IDs:
Open or close this module Study Status
Record Verification: October 2016
Overall Status: Not yet recruiting
Study Start: November 2016
Primary Completion: March 2019 [Anticipated]
Study Completion: March 2019 [Anticipated]
First Submitted: October 28, 2016
First Submitted that
Met QC Criteria:
October 28, 2016
First Posted: October 31, 2016 [Estimate]
Last Update Submitted that
Met QC Criteria:
October 28, 2016
Last Update Posted: October 31, 2016 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Daiichi Sankyo, Inc.
Responsible Party: Sponsor
Collaborators: SSS International Clinical Research GmbH
Hippocrates Research
IMS Health
ITEC Services
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module 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.
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.
Open or close this module Conditions
Conditions: Atrial Fibrillation
Venous Thromboembolism
Keywords: Diagnostic procedures
Interventional procedures
Planned or unplanned
Edoxaban-treated population
Open or close this module Study Design
Study Type: Observational [Patient Registry]
Observational Study Model: Cohort
Time Perspective: Prospective
Biospecimen Retention:
Biospecimen Description:
Enrollment: 2000 [Anticipated]
Number of Groups/Cohorts 1
Target Follow-Up Duration: 30 Days
Open or close this module Groups and Interventions
Groups/Cohorts Interventions
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 Names:
  • Lixiana
Open or close this module Outcome Measures
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
Open or close this module Eligibility
Study Population: Edoxaban-treated patients with NVAF, VAT or PE undergoing planned or unplanned diagnostic or interventional procedures
Sampling Method: Non-Probability Sample
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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
Open or close this module Contacts/Locations
Central Contact Person: Rachael King
Telephone: +49 (89) 800650-0
Email: Rachael.King@cro-sss.de
Central Contact Backup: Maria Liebig
Telephone: +49 (89) 800650-32
Email: maria.liebig@cro-sss.de
Study Officials: Martin Unverdorben Unverdorben, Prof., Dr. med
Study Director
Daiichi Sankyo, Inc.
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations: 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. PubMed 24251359
Links:
Available IPD/Information:

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