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;