Clinical trial · Interventional
Cancer Venous Thromboembolism (VTE)
A Phase 3b, Prospective, Randomized, Open-label, Blind Evaluator (PROBE) Study Evaluating the Efficacy and Safety of (LMW) Heparin/Edoxaban Versus Dalteparin in Venous Thromboembolism Associated With Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Deep Vein Thrombosis (DVT) | — | UNRESOLVED | — |
| Pulmonary Embolism (PE) | — | UNRESOLVED | — |
| Venous Thromboembolism (VTE) | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dalteparin | Drug | — | UNRESOLVED |
| Edoxaban | Drug | — | UNRESOLVED |
| Low molecular weight heparin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Edoxaban group
- description
- After 5 days of low molecular weight heparin (LMWH), patients receive edoxaban treatment daily - tablet for oral use
- interventionNames
- Drug: Edoxaban
- Drug: Low molecular weight heparin
- type
- ACTIVE_COMPARATOR
- label
- Dalteparin group
- description
- Participants receive Dalteparin treatment daily -solution for subcutaneous injection
- interventionNames
- Drug: Dalteparin
Primary outcomes (1)
- measure
- Number of Participants With Adjudicated Recurrent Venous Thromboembolism (VTE) or Major Bleeding Event
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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;
References
Publications (3)
- DERIVEDPatell R, Hsu C, Shi M, Grosso MA, Duggal A, Buller HR, Raskob G, Zwicker JI. Impact of mild thrombocytopenia on bleeding and recurrent thrombosis in cancer. Haematologica. 2024 Jun 1;109(6):1849-1856. doi: 10.3324/haematol.2023.284192. PMID 37855029
- DERIVEDRaskob GE, van Es N, Verhamme P, Carrier M, Di Nisio M, Garcia D, Grosso MA, Kakkar AK, Kovacs MJ, Mercuri MF, Meyer G, Segers A, Shi M, Wang TF, Yeo E, Zhang G, Zwicker JI, Weitz JI, Buller HR; Hokusai VTE Cancer Investigators. Edoxaban for the Treatment of Cancer-Associated Venous Thromboembolism. N Engl J Med. 2018 Feb 15;378(7):615-624. doi: 10.1056/NEJMoa1711948. Epub 2017 Dec 12. PMID 29231094
- DERIVEDvan Es N, Di Nisio M, Bleker SM, Segers A, Mercuri MF, Schwocho L, Kakkar A, Weitz JI, Beyer-Westendorf J, Boda Z, Carrier M, Chlumsky J, Decousus H, Garcia D, Gibbs H, Kamphuisen PW, Monreal M, Ockelford P, Pabinger I, Verhamme P, Grosso MA, Buller HR, Raskob GE. Edoxaban for treatment of venous thromboembolism in patients with cancer. Rationale and design of the Hokusai VTE-cancer study. Thromb Haemost. 2015 Nov 25;114(6):1268-76. doi: 10.1160/TH15-06-0452. Epub 2015 Aug 13. PMID 26271200