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

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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
5
sites
2429
mi
from 98109
Norfolk, VA
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2533
mi
from 98109
Brandon, FL
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1933
mi
from 98109
Detroit, MI
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2190
mi
from 98109
Jonesboro, GA
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4940
mi
from 98109
Leuven,
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