Edoxaban Treatment in Routine Clinical Practice in Patients With Venous Thromboembolism in Europe (ETNA-VTE)
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|ClinicalTrials.gov Identifier: NCT02943993|
Recruitment Status : Active, not recruiting
First Posted : October 25, 2016
Last Update Posted : December 24, 2018
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|
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.
|Study Type :||Observational|
|Actual Enrollment :||2826 participants|
|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|
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.
Prescribed according to approved label
Other Name: Lixiana
- Percentage of participants with overall symptomatic VTE recurrence [ Time Frame: 18 months ]
- 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
- Percentage of participants taking edoxaban with symptomatic VTE recurrence [ Time Frame: 18 months ]
- Percentage of participants who permanently discontinued edoxaban with symptomatic VTE recurrence [ Time Frame: 18 months ]
- 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)
- 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
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
|International Clinical Research GmbH|
|Germering, Germany, 82110|
|Study Chair:||Alexander T Cohen, Dr. Med.||Department of Haematological Medicine, Guy's and St Thomas' NHS Foundation Trust|