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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.

Tracking Information
First Submitted Date October 28, 2016
First Posted Date October 31, 2016
Last Update Posted Date February 5, 2020
Study Start Date November 2016
Actual Primary Completion Date July 26, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 28, 2016)
  • 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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: October 28, 2016)
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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: October 28, 2016)
Number of procedures undergone by trial participants by type [ Time Frame: within the 2.5 year study ]
Categories: Planned and Unplanned
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Edoxaban Management in Diagnostic and Therapeutic Procedures
Official Title Edoxaban Management in Diagnostic and Therapeutic Procedures
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.
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 30 Days
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Edoxaban-treated patients with NVAF, VAT or PE undergoing planned or unplanned diagnostic or interventional procedures
Condition
  • Atrial Fibrillation
  • Venous Thromboembolism
Intervention Procedure: Edoxaban
Edoxaban according to Summary of Product Characteristic (SMPC)
Other Name: Lixiana
Study Groups/Cohorts Edoxaban
All patients treated with edoxaban with a planned or unplanned diagnostic or interventional procedure
Intervention: Procedure: Edoxaban
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 13, 2018)
1197
Original Estimated Enrollment
 (submitted: October 28, 2016)
2000
Actual Study Completion Date July 26, 2018
Actual Primary Completion Date July 26, 2018   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT02950168
Other Study ID Numbers DSE-EDO-02-15-EU
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: 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/
Current Responsible Party Daiichi Sankyo, Inc.
Original Responsible Party Same as current
Current Study Sponsor Daiichi Sankyo, Inc.
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Study Director: Global Clinical Leader Daiichi Sankyo, Inc.
PRS Account Daiichi Sankyo, Inc.
Verification Date February 2020