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Edoxaban Treatment in Routine Clinical Practice in Patients With Venous Thromboembolism in Europe (ETNA-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: NCT02943993
Recruitment Status : Active, not recruiting
First Posted : October 25, 2016
Last Update Posted : December 24, 2018
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.

Brief Summary:

According to current guidelines, duration of anticoagulant treatment after a venous thromboembolic event varies from 3 months to indefinite treatment depending on the estimated risks of venous thromboembolism (VTE) recurrence and bleeding. Current data for edoxaban are limited to a maximum treatment duration of 12 months (Hokusai-VTE; N Engl J Med. 2013; 369:1406-15).

Therefore, this study aims to gather further insight into efficacy (i.e. symptomatic recurrent VTE) and safety (i.e. bleeding events, liver adverse events, all-cause mortality and other drug related adverse events) of extended treatment with edoxaban up to 18 months in an unselected patient population in routine clinical practice.


Condition or disease Intervention/treatment
Venous Thromboembolism Drug: Edoxaban

Detailed Description:

Real-world evidence data in routine clinical practice use of edoxaban up to 18 months will be collected in 2,700 patients, treated by specialized as well as non-specialized physicians in hospitals and office based centres in 11 European countries. Patients from different countries and care settings (primary care and secondary care, different specialties) to ensure representativeness and extended assessment is planned for collection of VTE recurrences for up to 18 months after last data collection point for patients who entered the study early. The enrollment period of patients will be 2 years per country. Documentation of baseline and follow up information at 1, 3, 6, 12, and 18 months (only when available) will be collected. In addition, recurrence of symptomatic VTE and death will be captured retrospectively at time point of Last Patient Out per country.

Patients who discontinue permanently edoxaban during the observational period will be followed up according to the same scheme. The results gained in ETNA-VTE-Europe will be compared to data from the PREFER in VTE disease registry. The PREFER registry, was selected as it is similar in bleeding definition, comparable in data collection point schedules, with a robust number of patients (~3,500 patients) enrolled.


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Study Type : Observational
Actual Enrollment : 2826 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non-Interventional Study on Edoxaban Treatment in Routine Clinical Practice in Patients With Venous Thromboembolism in Europe
Study Start Date : August 2015
Estimated Primary Completion Date : November 5, 2020
Estimated Study Completion Date : November 5, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Edoxaban

Group/Cohort Intervention/treatment
Patients treated with Edoxaban
Patients with established acute initial or recurrent VTE treated with edoxaban according to Summary of Product Characteristics (SmPC). Physician's prescribing behaviour will not be influenced, patients may only be included after the treating physician has made the clinical decision to prescribe edoxaban.
Drug: Edoxaban
Prescribed according to approved label
Other Name: Lixiana




Primary Outcome Measures :
  1. Percentage of participants with overall symptomatic VTE recurrence [ Time Frame: 18 months ]
  2. Percentage of participants experiencing Real World Safety Data Events [ Time Frame: 18 months ]
    Categories: VTE-related bleeding events, Drug-related adverse events, Cardiovascular Mortality, and All-cause Mortality


Secondary Outcome Measures :
  1. Percentage of participants taking edoxaban with symptomatic VTE recurrence [ Time Frame: 18 months ]
  2. Percentage of participants who permanently discontinued edoxaban with symptomatic VTE recurrence [ Time Frame: 18 months ]

Other Outcome Measures:
  1. Percentage of participants with patient relevant outcomes [ Time Frame: 18 months ]
    Patient relevant outcomes include strokes (ischaemic and haemorrhagic), systemic embolic events (SEE), hospitalisations related to cardiovascular (CV) condition (including VTE related hospitalisation), post-thrombotic syndrome (PTS)

  2. Percentage of participants compliant with edoxaban therapy [ Time Frame: over 18 months ]
    Categories: Always, Almost Always, Most of the Time, Less than Half the Time, Unknown



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
All patients with established acute initial or recurrent VTE treated with edoxaban according to Summary of Product Characteristics (SmPC). To ensure that the physician's prescribing behaviour will not be influenced, patients may only be included after the treating physician has made the clinical decision to prescribe edoxaban. Patients must have provided written informed consent for participation in the study (ICF) and should not participate simultaneously in any interventional study.
Criteria

Inclusion Criteria:

  • Established acute initial or recurrent VTE
  • Patients prescribed treatment with edoxaban according to Summary of Product Characteristics (SmPC) before participation in the trial
  • Written informed consent for participation in the study (ICF)
  • Not simultaneously participating in any interventional study

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): NCT02943993


Locations
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Germany
International Clinical Research GmbH
Germering, Germany, 82110
Sponsors and Collaborators
Daiichi Sankyo, Inc.
Investigators
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Study Chair: Alexander T Cohen, Dr. Med. Department of Haematological Medicine, Guy's and St Thomas' NHS Foundation Trust

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Daiichi Sankyo, Inc.
ClinicalTrials.gov Identifier: NCT02943993     History of Changes
Other Study ID Numbers: DSE-EDO-05-14-EU
First Posted: October 25, 2016    Key Record Dates
Last Update Posted: December 24, 2018
Last Verified: September 2018
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.:
Post-Authorisation Safety Study
Real World Evidence
Edoxaban
Efficacy/Safety

Additional relevant MeSH terms:
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Thromboembolism
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Edoxaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants