Cancer Venous Thromboembolism (VTE)

Phase 3

Completed

Conditions: Venous Thromboembolism (VTE)
Deep Vein Thrombosis (DVT)
Pulmonary Embolism (PE)
Cancer

Interventions: Drug: Edoxaban
Drug: Dalteparin
Drug: Low molecular weight heparin

Brief 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.

Recruitment & Eligibility

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;

Arm && Interventions

Group	Intervention	Description
Edoxaban group	Low molecular weight heparin	After 5 days of low molecular weight heparin (LMWH), patients receive edoxaban treatment daily - tablet for oral use
Edoxaban group	Edoxaban	After 5 days of low molecular weight heparin (LMWH), patients receive edoxaban treatment daily - tablet for oral use
Dalteparin group	Dalteparin	Participants receive Dalteparin treatment daily -solution for subcutaneous injection

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adjudicated Recurrent Venous Thromboembolism (VTE) or Major Bleeding Event	12 months

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Adjudicated Major Bleeding Events While on Treatment	12 months	The primary safety endpoint was major bleeding events during the On-Treatment Study Period (defined as on-study drug or up to 3 days after the last dose of study drug).
Number of Participants With Recurrent Venous Thromboembolism (VTE) During the Overall Study Period	12 months
Number of Participants With Recurrent Deep Vein Thrombosis (DVT) During the Overall Study Period	12 months
Number of Participants With Recurrent VTE, Major Bleed or All-Cause Death	12 months
Number of Participants With Recurrent Non-Fatal Pulmonary Embolism (PE) During the Overall Study Period	12 months
Number of Participants With VTE-Related Death	12 months