Overview

Cancer Venous Thromboembolism (VTE)

Status:
Completed
Trial end date:
2017-09-15
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Daiichi Sankyo Inc.
Daiichi Sankyo, Inc.
Treatments:
Dalteparin
Edoxaban
Heparin
Heparin, Low-Molecular-Weight
Tinzaparin
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;