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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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German Clinical Trials Register |
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Last refreshed on:
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8 April 2024 |
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Main ID: |
DRKS00007934 |
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Date of registration:
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30/07/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Non-Interventional Study on Edoxaban Treatment in Routine Clinical Practice in Patients
with Venous Thromboembolism in Europe
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Scientific title:
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Non-Interventional Study on Edoxaban Treatment in Routine Clinical Practice in Patients
with Venous Thromboembolism in Europe - ETNA-VTE-Europe |
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Date of first enrolment:
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26/08/2015 |
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Target sample size:
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2700 |
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Recruitment status: |
Complete |
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URL:
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http://drks.de/search/en/trial/DRKS00007934 |
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Study type:
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observational |
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Study design:
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Allocation: ; Masking: ; Control: ; Assignment: ; Study design purpose: treatment
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Phase:
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Countries of recruitment
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Austria
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Belgium
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France
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Germany
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Ireland
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Italy
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Netherlands
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Portugal
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Spain
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Switzerland
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United Kingdom
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Contacts
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Name:
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Petra
Laeis |
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Address:
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Zielstattstr. 48
81379
München
Germany |
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Telephone:
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+49 89 7808-614 |
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Email:
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petra.laeis@daiichi-sankyo.eu |
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Affiliation:
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Daiichi Sankyo Europe GmbH |
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Name:
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Petra
Laeis |
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Address:
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Zielstattstr. 48
81379
München
Germany |
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Telephone:
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+49 89 7808-614 |
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Email:
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petra.laeis@daiichi-sankyo.eu |
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Affiliation:
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Daiichi Sankyo Europe GmbH |
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Key inclusion & exclusion criteria
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Inclusion criteria: - Established acute initial or recurrent VTE
- Patients treated with edoxaban according to Summary of Product Characteristics (SmPC).
- Written informed consent for participation in the study (ICF)
- Not simultaneously participating in any interventional study
As this is a non-interventional study, no additional selection criteria apply. Patients will only be included in the study after the treating physician has made the clinical decision to prescribe Edoxaban. The prescription behavior will not be influenced.
Exclusion criteria: Not applicable
Age minimum:
18 Years
Age maximum:
None
Gender:
All
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Health Condition(s) or Problem(s) studied
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Other venous embolism and thrombosis
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MedDRA - 10066899: Venous thromboembolism
I82
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Intervention(s)
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Group 1: - Patients from different countries and care settings (primary and secondary care and different specialties) with acute venous thromboembolism (VTE) treated with Edoxaban according to the summary of product characteristics (SmPC).
- Recommended visits: Baseline plus follow-up visits after 1, 3, 6, 12 and 18 months including a final assessment.
- Patients who permanently discontinue Edoxaban during the 18 months observation period will be followed up until the end of the observation period.
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Primary Outcome(s)
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Primary objective is the analysis of the overall symptomatic VTE recurrence rate during an overall observational period of 18 months in unselected patients with acute VTE.
The co-primary objective of this study is to collect real world safety data on bleeding events, drug related adverse events such as liver adverse events, and mortality (VTE-related and all-cause) in patients treated with edoxaban. Furthermore, safety analyses in pre-specified subpopulations such as patients with renal impairment and patients with hepatic impairment will be performed.
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Secondary Outcome(s)
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To assess the effect of edoxaban on relevant patient outcomes as recurrence rate of symptomatic VTE during edoxaban treatment, recurrence rate of symptomatic VTE after cessation of edoxaban treatment, hospitalisations, post-thrombotic syndrome, persistence to therapy, patient/physician reported outcomes, health care utilization, resource use
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Secondary ID(s)
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DSE-EDO-05-14-EU
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Source(s) of Monetary Support
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Daiichi Sankyo Europe GmbH
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Ethics review
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Status: Approved
Approval date: 06/07/2015
Contact:
ethikkommission@med.uni-muenchen.de
Ethikkommission der Med. Fakultät der LMU
+49-89-440055191
ethikkommission@med.uni-muenchen.de
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