Cancer Venous Thromboembolism (VTE)

Daiichi Sankyo

Status and phase

Completed

Phase 3

Conditions

Venous Thromboembolism (VTE)

Deep Vein Thrombosis (DVT)

Cancer

Pulmonary Embolism (PE)

Treatments

Drug: Dalteparin

Drug: Edoxaban

Drug: Low molecular weight heparin

Study type

Interventional

Funder types

Industry

Identifiers

NCT02073682

DU176b-D-U311

2014-004708-30 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

1,046 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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;