Cancer Venous Thromboembolism (VTE)

Status:	Completed
Conditions:	Cancer, Cancer, Cardiology, Cardiology, Cardiology, Cardiology
Therapuetic Areas:	Cardiology / Vascular Diseases, Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	3/8/2019
Start Date:	July 16, 2015
End Date:	September 15, 2017

A Phase 3b, Prospective, Randomized, Open-label, Blind Evaluator (PROBE) Study Evaluating the Efficacy and Safety of (LMW) Heparin/Edoxaban Versus Dalteparin in Venous Thromboembolism Associated With Cancer

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.

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;

We found this trial at

sites

Clinical Trial Facility in Leuven Vlaams-Brabant

Leuven, Vlaams-Brabant

from

Leuven,