N/A
N=2,655
Edoxaban Treatment in Routine Clinical Practice in Patients With Venous Thromboembolism in Europe
Venous Thromboembolism
Bottom Line
View on ClinicalTrials.gov: NCT02943993 ↗Enrolled (actual)
2,655
Serious AEs
—
Results posted
May 2022
Primary outcome: Primary: Percentage of Participants With At Least 1 Symptomatic Venous Thromboembolism Recurrence - Overall — 3.8 Percentage of VTE recurrence
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Edoxaban (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With At Least 1 Symptomatic Venous Thromboembolism Recurrence - Overall |
3.8 | — |
| PRIMARY Number of Participants With Bleeding Events (Adjudicated) While On Edoxaban Treatment |
304; 38; 82; 300; 77; 4 | — |
| SECONDARY Percentage of Participants Experiencing At Least 1 Real World Safety Event - Overall |
2.3; 0.3; 1.2; 3.6; 0.9; 0 | — |
| SECONDARY Percentage of Participants With At Least 1 Symptomatic Venous Thromboembolism Recurrence - On Edoxaban Treatment |
1.4; 1.0; 0; 0.3; 1.9; 0.4 | — |
| SECONDARY Total Number of Venous Thromboembolism Recurrences By Type - Overall |
105; 64; 7; 32 | — |
| SECONDARY Duration of Venous Thromboembolism Recurrences, by Type - Overall |
18.0; 44.5; 8.0; 16.0 | — |
| SECONDARY Total Number of Venous Thromboembolism Recurrences (On Edoxaban Treatment) |
39; 28; 1; 9 | — |
| SECONDARY Duration of Venous Thromboembolism Events (On Edoxaban Treatment) |
11.0; 9.5; 0; 15.0 | — |
| SECONDARY Number of Participants With Risk Factors for Thromboembolic Events at Baseline |
9; 401; 218; 359; 111 | — |
| SECONDARY Duration of Edoxaban Treatment |
2527; 2346; 1842; 1272; 713; 1910 | — |
| SECONDARY Number of Stroke Events |
27; 17; 5; 5; 16; 12 | — |
| SECONDARY Number of Systemic Embolic Events - Overall |
1; 1 | — |
| SECONDARY Overview of Participants With Adverse Drug Reactions |
2; 142; 59; 0 | — |
| SECONDARY Number of Participants With Adverse Drug Reactions by Preferred Term (≥0.2%) |
35; 12; 12; 11; 8; 8 | — |
| SECONDARY Number of Participants With Pre-defined Adverse Drug Reactions |
2; 75; 0; 0; 0; 4 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02943993). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.