Venous ThromboembolismETNA-VTENCT02943993
Edoxaban Treatment in Routine Clinical Practice in Patients With Venous Thromboembolism in Europe
An observational study of Venous Thromboembolism, run by Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thromboembolism
- What is being tested?
- Edoxaban
- How many people
- 2,809 participants
- Where
- 1 siteGermany
- Study dates
- 6 Apr 2016to 1 Dec 2020
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients with established initial or recurrent acute symptomatic VTE (distal or proximal deep vein thrombosis/pulmonary embolism) treated with edoxaban according to the 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.
Who may be able to join
- Established acute initial or recurrent VTE
- Clinical decision for treatment with edoxaban is made at the time of enrollment
- Written informed consent for participation in the study (ICF)
- Not simultaneously participating in any interventional study
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-Interventional Study on Edoxaban Treatment in Routine Clinical Practice in Patients With Venous Thromboembolism in Europe
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.
Read the 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 8 European countries. Patients from different countries and care settings (primary care and secondary care, different specialties) will be enrolled in this post-authorization safety study. 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.
- Conditions
- Venous Thromboembolism
- Being tested
- Edoxaban
- Keywords
- Post-Authorisation Safety Study, Real World Evidence, Edoxaban, Efficacy/Safety
- Medical subject headings
- Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EdoxabanDrug
Also called Lixiana
Prescribed according to approved label
| Study group | Role | What they receive |
|---|---|---|
| Patients treated with Edoxaban | Patients with established initial or recurrent acute symptomatic VTE treated with edoxaban according to the 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. Receives: Drug: Edoxaban |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With At Least 1 Symptomatic Venous Thromboembolism Recurrence - Overall
Descriptive statistics were used to report the number of participants with at least 1 symptomatic VTE recurrence. Recurrent VTE events were based on adjudicated events.
For the overall symptomatic VTE, precentage of participants (including 95% confidence intervals) were calculated.
Measured: Baseline up to end of observation period (18 months)
Number of Participants With Bleeding Events (Adjudicated) While On Edoxaban Treatment
Descriptive statistics were used to report the number of participants with bleeding events.
For the analysis of bleeding events, absolute number of participants were calculated.
Measured: Baseline up to end of observation period (18 months)
Secondary outcomes (13)
Percentage of Participants Experiencing At Least 1 Real World Safety Event - Overall
Descriptive statistics were used to report the number of participants experiencing recurrent VTE and at least 1 real world safety event. VTE recurrence data were reported by recurrent deep vein thrombosis (DVT), recurrent pulmonary embolism (PE) with DVT, and recurrent PE only. Recurrent VTE events were based on adjudicated events. Real world safety events included all-cause death, cardiovascular (CV)-related death, VTE-related death, stroke, systemic embolic event, and hospitalization related to CV.
For recurrent VTE and real world safety events, absolute and relative frequencies (including 95% confidence intervals) were calculated.
Measured: Baseline up to end of observation period (18 months)
Percentage of Participants With At Least 1 Symptomatic Venous Thromboembolism Recurrence - On Edoxaban Treatment
Descriptive statistics were used to report the number of participants with overall symptomatic VTE recurrence. VTE recurrence data were further reported by recurrent deep venous thrombosis (DVT), recurrent pulmonary embolism (PE) with deep venous thrombosis (DVT), and recurrent PE only. Recurrent VTE events were based on adjudicated events.
For symptomatic VTE recurrence, percentage of participants (95% confidence intervals) were calculated.
Measured: Baseline up to end of observation period (18 months)
Total Number of Venous Thromboembolism Recurrences By Type - Overall
Descriptive statistics were used to describe the number of VTE events reported by the patient.
For VTE recurrences, absolute number of VTE events were calculated.
Measured: Baseline up to end of observation period (18 months)
Duration of Venous Thromboembolism Recurrences, by Type - Overall
Descriptive statistics were used to assess the duration of VTE events reported by the patient.
For VTE recurrences, median duration of VTE events (interquartile range) were calculated.
Measured: Baseline up to end of observation period (18 months)
Total Number of Venous Thromboembolism Recurrences (On Edoxaban Treatment)
Descriptive statistics were used to assess the number of recurrent VTE events reported by the patient.
For VTE recurrences, absolute number of VTE recurrences were calculated.
Measured: Baseline up to end of observation period (18 months)
Duration of Venous Thromboembolism Events (On Edoxaban Treatment)
Descriptive statistics were used to assess the duration of VTE events reported by the patient.
For VTE events, median duration of VTE events (interquartile range) were calculated.
Measured: Baseline up to end of observation period (18 months)
Number of Participants With Risk Factors for Thromboembolic Events at Baseline
Descriptive statistics were used to assess the number of participants with risk factors for thromboembolic events.
For risk factors for thromboembolic events, absolute number of participants with risk factors (percentage) were calculated.
Measured: at Baseline
Duration of Edoxaban Treatment
Descriptive statistics were used to report the duration of edoxaban treatment.
Measured: Baseline up to end of observational period (18 months)
Number of Stroke Events
Descriptive statistics were used to report the number of stroke events.
For stroke events, absolute number of stroke events were calculated.
Measured: Baseline up to end of observation period (18 months)
Number of Systemic Embolic Events - Overall
Descriptive statistics were used to report the number of systemic embolic events (SEE).
For SEE, absolute SEEs were calculated.
Measured: Baseline up to end of observation period (18 months)
Overview of Participants With Adverse Drug Reactions
Descriptive statistics were used to report an overview of participants with adverse drug reactions (ADR). ADRs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 20.1.
Measured: Baseline up to end of observation period (18 months)
Number of Participants With Adverse Drug Reactions by Preferred Term (≥0.2%)
Adverse drug reactions were reported and coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 20.1.
Measured: Baseline up to end of observational period (18 months)
Number of Participants With Pre-defined Adverse Drug Reactions
Descriptive statistics were used to report the number of participants with pre-defined adverse drug reactions (ADR). ADRs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 20.1.
Measured: Baseline up to end of observation period (18 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2016 (estimated)
- Study start6 Apr 2016
- Primary completion1 Dec 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,809 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Leader, Study director, Daiichi Sankyo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02943993
- Sponsor's protocol ID
- DSE-EDO-05-14-EU
- Acronym
- ETNA-VTE
- Status last verified
- Mar 2025
- First submitted
- 24 Oct 2016
- Last updated
- 1 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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 24251359Hokusai-VTE Investigators; Buller HR, Decousus H, Grosso MA, Mercuri M, Middeldorp S, Prins MH, Raskob GE, Schellong SM, Schwocho L, Segers A, Shi M, Verhamme P, Wells P. Edoxaban versus warfarin for the treatment of symptomatic venous thromboembolism. N Engl J Med. 2013 Oct 10;369(15):1406-15. doi: 10.1056/NEJMoa1306638. Epub 2013 Aug 31.
PubMed 23991658Cohen AT, Hoffmann U, Hainaut P, Gaine S, Ay C, Coppens M, Schindewolf M, Jimenez D, Bruggenjurgen B, Levy P, Laeis P, Fronk EM, Zierhut W, Malzer T, Manu MC, Reimitz PE, Bramlage P, Agnelli G; ETNA-VTE-Europe investigators. ETNA VTE Europe: A contemporary snapshot of patients treated with edoxaban in clinical practice across eight European countries. Eur J Intern Med. 2020 Dec;82:48-55. doi: 10.1016/j.ejim.2020.08.014. Epub 2020 Aug 18.
PubMed 32826158Cohen AT, Ay C, Hainaut P, Decousus H, Hoffmann U, Gaine S, Coppens M, da Silva PM, Castro DJ, Amann-Vesti B, Bruggenjurgen B, Levy P, Bastida JL, Vicaut E, Laeis P, Fronk EM, Zierhut W, Malzer T, Bramlage P, Agnelli G; ETNA-VTE-Europe investigators. Design and rationale of the non-interventional, edoxaban treatment in routiNe clinical prActice in patients with venous ThromboEmbolism in Europe (ETNA-VTE-Europe) study. Thromb J. 2018 May 1;16:9. doi: 10.1186/s12959-018-0163-7. eCollection 2018.
PubMed 29719492
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Interventional Study on Edoxaban Treatment in Routine Clinical Practice in Patients With Venous Thromboembolism in Europe
- ClinicalTrials.gov ID
- NCT02943993
- Acronym / sponsor ID
- ETNA-VTE / DSE-EDO-05-14-EU
- Conditions
- Venous Thromboembolism
- Keywords
- Post-Authorisation Safety Study, Real World Evidence, Edoxaban, Efficacy/Safety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,809 participants (actual)
- Lead sponsor
- Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo CompanyIndustry (pharma, biotech, devices)
- Study start
- 6 Apr 2016 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 25 Oct 2016 (estimated)
- Results
- Posted 2 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 8 European countries. Patients from different countries and care settings (primary care and secondary care, different specialties) will be enrolled in this post-authorization safety study. 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients treated with Edoxaban | – | Drug: EdoxabanPatients with established initial or recurrent acute symptomatic VTE treated with edoxaban according to the 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with established initial or recurrent acute symptomatic VTE (distal or proximal deep vein thrombosis/pulmonary embolism) treated with edoxaban according to the 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.
Key inclusion criteria (4 listed)
- Established acute initial or recurrent VTE
- Clinical decision for treatment with edoxaban is made at the time of enrollment
- Written informed consent for participation in the study (ICF)
- Not simultaneously participating in any interventional study
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EdoxabanAlso: LixianaPrescribed according to approved label | Drug | Patients treated with Edoxaban |
Primary outcome
Percentage of Participants With At Least 1 Symptomatic Venous Thromboembolism Recurrence - Overall
Time frame: Baseline up to end of observation period (18 months)
Descriptive statistics were used to report the number of participants with at least 1 symptomatic VTE recurrence. Recurrent VTE events were based on adjudicated events. For the overall symptomatic VTE, precentage of participants (including 95% confidence intervals) were calculated.
Number of Participants With Bleeding Events (Adjudicated) While On Edoxaban Treatment
Time frame: Baseline up to end of observation period (18 months)
Descriptive statistics were used to report the number of participants with bleeding events. For the analysis of bleeding events, absolute number of participants were calculated.
13 secondary outcomes
Percentage of Participants Experiencing At Least 1 Real World Safety Event - Overall
Time frame: Baseline up to end of observation period (18 months)
Percentage of Participants With At Least 1 Symptomatic Venous Thromboembolism Recurrence - On Edoxaban Treatment
Time frame: Baseline up to end of observation period (18 months)
Total Number of Venous Thromboembolism Recurrences By Type - Overall
Time frame: Baseline up to end of observation period (18 months)
Duration of Venous Thromboembolism Recurrences, by Type - Overall
Time frame: Baseline up to end of observation period (18 months)
Total Number of Venous Thromboembolism Recurrences (On Edoxaban Treatment)
Time frame: Baseline up to end of observation period (18 months)
Duration of Venous Thromboembolism Events (On Edoxaban Treatment)
Time frame: Baseline up to end of observation period (18 months)
Number of Participants With Risk Factors for Thromboembolic Events at Baseline
Time frame: at Baseline
Duration of Edoxaban Treatment
Time frame: Baseline up to end of observational period (18 months)
Number of Stroke Events
Time frame: Baseline up to end of observation period (18 months)
Number of Systemic Embolic Events - Overall
Time frame: Baseline up to end of observation period (18 months)
Overview of Participants With Adverse Drug Reactions
Time frame: Baseline up to end of observation period (18 months)
Number of Participants With Adverse Drug Reactions by Preferred Term (≥0.2%)
Time frame: Baseline up to end of observational period (18 months)
Number of Participants With Pre-defined Adverse Drug Reactions
Time frame: Baseline up to end of observation period (18 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24251359Giugliano 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.
- Background: PubMed 23991658Hokusai-VTE Investigators; Buller HR, Decousus H, Grosso MA, Mercuri M, Middeldorp S, Prins MH, Raskob GE, Schellong SM, Schwocho L, Segers A, Shi M, Verhamme P, Wells P. Edoxaban versus warfarin for the treatment of symptomatic venous thromboembolism. N Engl J Med. 2013 Oct 10;369(15):1406-15. doi: 10.1056/NEJMoa1306638. Epub 2013 Aug 31.
- Derived from this study: PubMed 32826158Cohen AT, Hoffmann U, Hainaut P, Gaine S, Ay C, Coppens M, Schindewolf M, Jimenez D, Bruggenjurgen B, Levy P, Laeis P, Fronk EM, Zierhut W, Malzer T, Manu MC, Reimitz PE, Bramlage P, Agnelli G; ETNA-VTE-Europe investigators. ETNA VTE Europe: A contemporary snapshot of patients treated with edoxaban in clinical practice across eight European countries. Eur J Intern Med. 2020 Dec;82:48-55. doi: 10.1016/j.ejim.2020.08.014. Epub 2020 Aug 18.
- Derived from this study: PubMed 29719492Cohen AT, Ay C, Hainaut P, Decousus H, Hoffmann U, Gaine S, Coppens M, da Silva PM, Castro DJ, Amann-Vesti B, Bruggenjurgen B, Levy P, Bastida JL, Vicaut E, Laeis P, Fronk EM, Zierhut W, Malzer T, Bramlage P, Agnelli G; ETNA-VTE-Europe investigators. Design and rationale of the non-interventional, edoxaban treatment in routiNe clinical prActice in patients with venous ThromboEmbolism in Europe (ETNA-VTE-Europe) study. Thromb J. 2018 May 1;16:9. doi: 10.1186/s12959-018-0163-7. eCollection 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Leader study director
Daiichi Sankyo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Venous Thromboembolism, run by Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With At Least 1 Symptomatic Venous Thromboembolism Recurrence - Overall (time frame: Baseline up to end of observation period (18 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02943993, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2025.