Clinical trial NCT02943993: Edoxaban Treatment in Routine Clinical Practice in Patients With Venous Thromboembolism in Europe
Official title: Non-Interventional Study on Edoxaban Treatment in Routine Clinical Practice in Patients With Venous Thromboembolism in Europe
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Venous Thromboembolism
Keywords: Post-Authorisation Safety Study
Real World Evidence
Edoxaban
Efficacy/Safety
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2016-10-25
Enrollment: 2809
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* None

Primary outcomes:
measure: Percentage of Participants With At Least 1 Symptomatic Venous Thromboembolism Recurrence - Overall
timeFrame: Baseline up to end of observation period (18 months)
measure: Number of Participants With Bleeding Events (Adjudicated) While On Edoxaban Treatment
timeFrame: Baseline up to end of observation period (18 months)
Secondary outcomes:
measure: Percentage of Participants Experiencing At Least 1 Real World Safety Event - Overall
timeFrame: Baseline up to end of observation period (18 months)
measure: Percentage of Participants With At Least 1 Symptomatic Venous Thromboembolism Recurrence - On Edoxaban Treatment
timeFrame: Baseline up to end of observation period (18 months)
measure: Total Number of Venous Thromboembolism Recurrences By Type - Overall
timeFrame: Baseline up to end of observation period (18 months)
measure: Duration of Venous Thromboembolism Recurrences, by Type - Overall
timeFrame: Baseline up to end of observation period (18 months)
measure: Total Number of Venous Thromboembolism Recurrences (On Edoxaban Treatment)
timeFrame: Baseline up to end of observation period (18 months)
measure: Duration of Venous Thromboembolism Events (On Edoxaban Treatment)
timeFrame: Baseline up to end of observation period (18 months)
measure: Number of Participants With Risk Factors for Thromboembolic Events at Baseline
timeFrame: at Baseline
measure: Duration of Edoxaban Treatment
timeFrame: Baseline up to end of observational period (18 months)
measure: Number of Stroke Events
timeFrame: Baseline up to end of observation period (18 months)
measure: Number of Systemic Embolic Events - Overall
timeFrame: Baseline up to end of observation period (18 months)
measure: Overview of Participants With Adverse Drug Reactions
timeFrame: Baseline up to end of observation period (18 months)
measure: Number of Participants With Adverse Drug Reactions by Preferred Term (≥0.2%)
timeFrame: Baseline up to end of observational period (18 months)
measure: Number of Participants With Pre-defined Adverse Drug Reactions
timeFrame: Baseline up to end of observation period (18 months)
Other outcomes:
Locations:
city: Germering
country: Germany
facility: International Clinical Research GmbH
Study officials:
affiliation: Daiichi Sankyo
name: Global Clinical Leader
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Hokusai-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.
citation: Cohen 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.
citation: Cohen 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.