Edoxaban Treatment in Routine Clinical Practice in Patients With Venous Thromboembolism in Europe

Venous Thromboembolism Clinical Trial

— ETNA-VTE  

Official title:

Non-Interventional Study on Edoxaban Treatment in Routine Clinical Practice in Patients With Venous Thromboembolism in Europe

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02943993
• Other study ID #: DSE-EDO-05-14-EU
• Status: Completed
• Start date: April 6, 2016
• Est. completion date: December 1, 2020

Study information

• Verified date: February 2022
• Source: Daiichi Sankyo, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2809
• Est. completion date: December 1, 2020
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolism

Intervention

Drug:
• Edoxaban
Prescribed according to approved label

Locations

Country	Name	City	State
Germany	International Clinical Research GmbH	Germering

Sponsors (1)

Lead Sponsor	Collaborator
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company

Country where clinical trial is conducted

Germany, 

References & Publications (2)

Giugliano RP, Ruff CT, Braunwald E, Murphy SA, Wiviott SD, Halperin JL, Waldo AL, Ezekowitz MD, Weitz JI, Špinar 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. — View Citation

Hokusai-VTE Investigators, Büller HR, Décousus 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. Erratum in: N Engl J Med. 2014 Jan 23;370(4):390. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number 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.	Baseline up to end of observation period (18 months)
Primary	Number of Participants With Bleeding Events (Adjudicated) While On Edoxaban Treatment	Descriptive statistics were used to report the number of participants with bleeding events.	Baseline up to end of observation period (18 months)
Secondary	Number 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.	Baseline up to end of observation period (18 months)
Secondary	Number 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.	Baseline up to end of observation period (18 months)
Secondary	Total Number of Venous Thromboembolism Recurrences By Type - Overall	Descriptive statistics were used to describe the number of VTE events reported by the patient.	Baseline up to end of observation period (18 months)
Secondary	Duration of Venous Thromboembolism Recurrences, by Type - Overall	Descriptive statistics were used to assess the duration of VTE events reported by the patient.	Baseline up to end of observation period (18 months)
Secondary	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.	Baseline up to end of observation period (18 months)
Secondary	Duration of Venous Thromboembolism Events (On Edoxaban Treatment)	Descriptive statistics were used to assess the duration of VTE events reported by the patient.	Baseline up to end of observation period (18 months)
Secondary	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.	at Baseline
Secondary	Duration of Edoxaban Treatment	Descriptive statistics were used to report the duration of edoxaban treatment.	Baseline up to end of observational period (18 months)
Secondary	Number of Stroke Events	Descriptive statistics were used to report the number of stroke events.	Baseline up to end of observation period (18 months)
Secondary	Number of Systemic Embolic Events - Overall	Descriptive statistics were used to report the number of systemic embolic events (SEE).	Baseline up to end of observation period (18 months)
Secondary	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.	Baseline up to end of observation period (18 months)
Secondary	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.	Baseline up to end of observational period (18 months)
Secondary	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.	Baseline up to end of observation period (18 months)