Phase 3
N=1,046
Cancer Venous Thromboembolism (VTE)
Venous Thromboembolism (VTE) · Deep Vein Thrombosis (DVT) · Pulmonary Embolism (PE) · Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02073682 ↗Enrolled (actual)
1,046
Serious AEs
50.4%
Results posted
Oct 2018
Primary outcome: Primary: Number of Participants With Adjudicated Recurrent Venous Thromboembolism (VTE) or Major Bleeding Event — 67; 71 Participants — p=0.0056
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Edoxaban (Drug); Dalteparin (Drug); Low molecular weight heparin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Daiichi Sankyo
- Primary completion
- Sep 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adjudicated Recurrent Venous Thromboembolism (VTE) or Major Bleeding Event |
67; 71 | 0.0056 sig |
| SECONDARY Number of Participants With Adjudicated Major Bleeding Events While on Treatment |
32; 16 | 0.0254 sig |
| SECONDARY Number of Participants With Recurrent Venous Thromboembolism (VTE) During the Overall Study Period |
41; 59 | 0.0931 |
| SECONDARY Number of Participants With Recurrent Deep Vein Thrombosis (DVT) During the Overall Study Period |
19; 35 | 0.0394 sig |
| SECONDARY Number of Participants With Recurrent Non-Fatal Pulmonary Embolism (PE) During the Overall Study Period |
21; 24 | 0.7324 |
| SECONDARY Number of Participants With VTE-Related Death |
6; 4 | 0.4873 |
| SECONDARY Number of Participants With Recurrent VTE, Major Bleed or All-Cause Death |
235; 228 | 0.4199 |
Summary
The primary objective is to demonstrate the non-inferiority of edoxaban (preceded by a short course of LMWH) compared with dalteparin for the prevention of the combined outcome of recurrent venous thromboembolism (VTE) or major bleeding in subjects with VTE associated with cancer during a 12-month study period. If non-inferiority is established, LMWH/edoxaban will be compared with dalteparin for superiority.
Eligibility Criteria
Inclusion Criteria
- Male or female subjects with age ≥ 18 years or the otherwise legal lower age according to the country of residence;
- Confirmed acute lower extremity proximal DVT or PE for which long term treatment with low molecular weight heparin (LMWH) is indicated;
- Cancer, other than basal-cell or squamous-cell carcinoma of the skin;
- Able to provide written informed consent.
Exclusion Criteria
- Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current (index) episode of DVT and/or PE;
- Treatment with therapeutic doses of an anticoagulant other than that used for pretreatment of the current (index) VTE episode prior to randomization;
- Active bleeding or high risk for bleeding contraindicating treatment with LMWH or edoxaban;
- Any other contraindication listed in the local labeling of dalteparin, enoxaparin, or edoxaban;
Data sourced from ClinicalTrials.gov (NCT02073682). 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.