Cancer Venous Thromboembolism (VTE)
Completed · Phase 3
Conditions studied: Venous Thromboembolism (VTE), Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE), Cancer
In brief
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.
Key facts
- Study ID
- NCT02073682
- Run by
- Daiichi Sankyo
- People needed
- 1046
- Starts
- 2015-07-16
- Expected to finish
- 2017-09-15
- Last updated by the study team
- 2019-03-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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;
Where it is running
- Study site — Brandon, Florida, United States
- Study site — Jonesboro, Georgia, United States
- Study site — Detroit, Michigan, United States
- Study site — Norfolk, Virginia, United States
- Study site — Leuven, Vlaams-Brabant, Belgium
- Study site — Saint-Etienne, France
- Study site — Debrecen, Hajdu-Bihar Megye, Hungary
- Study site — Varese, Italy
- Study site — Amsterdam, Netherlands
Full record on ClinicalTrials.gov
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