Clinical trial NCT02073682: Cancer Venous Thromboembolism (VTE)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Venous Thromboembolism (VTE)
Deep Vein Thrombosis (DVT)
Pulmonary Embolism (PE)
Cancer
Keywords: Active Cancer with Metastasis
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2014-02-27
Enrollment: 1046
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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;

Primary outcomes:
measure: Number of Participants With Adjudicated Recurrent Venous Thromboembolism (VTE) or Major Bleeding Event
timeFrame: 12 months
Secondary outcomes:
measure: Number of Participants With Adjudicated Major Bleeding Events While on Treatment
timeFrame: 12 months
measure: Number of Participants With Recurrent Venous Thromboembolism (VTE) During the Overall Study Period
timeFrame: 12 months
measure: Number of Participants With Recurrent Deep Vein Thrombosis (DVT) During the Overall Study Period
timeFrame: 12 months
measure: Number of Participants With Recurrent Non-Fatal Pulmonary Embolism (PE) During the Overall Study Period
timeFrame: 12 months
measure: Number of Participants With VTE-Related Death
timeFrame: 12 months
measure: Number of Participants With Recurrent VTE, Major Bleed or All-Cause Death
timeFrame: 12 months
Other outcomes:
Locations:
city: Brandon
country: United States
state: Florida
city: Jonesboro
country: United States
state: Georgia
city: Detroit
country: United States
state: Michigan
city: Norfolk
country: United States
state: Virginia
city: Leuven
country: Belgium
state: Vlaams-Brabant
city: Saint-Etienne cedex 2
country: France
city: Debrecen
country: Hungary
state: Hajdu-Bihar Megye
city: Varese
country: Italy
city: Amsterdam
country: Netherlands
Study officials:
affiliation: Daiichi Sankyo
name: Global Clinical Leader
role: STUDY_DIRECTOR
References:
citation: Raskob GE, van Es N, Verhamme P, Carrier M, Di Nisio M, Garcia D, Grosso MA, Kakkar AK, Kovacs MJ, Mercuri MF, Meyer G, Segers A, Shi M, Wang TF, Yeo E, Zhang G, Zwicker JI, Weitz JI, Buller HR; Hokusai VTE Cancer Investigators. Edoxaban for the Treatment of Cancer-Associated Venous Thromboembolism. N Engl J Med. 2018 Feb 15;378(7):615-624. doi: 10.1056/NEJMoa1711948. Epub 2017 Dec 12.
citation: van Es N, Di Nisio M, Bleker SM, Segers A, Mercuri MF, Schwocho L, Kakkar A, Weitz JI, Beyer-Westendorf J, Boda Z, Carrier M, Chlumsky J, Decousus H, Garcia D, Gibbs H, Kamphuisen PW, Monreal M, Ockelford P, Pabinger I, Verhamme P, Grosso MA, Buller HR, Raskob GE. Edoxaban for treatment of venous thromboembolism in patients with cancer. Rationale and design of the Hokusai VTE-cancer study. Thromb Haemost. 2015 Nov 25;114(6):1268-76. doi: 10.1160/TH15-06-0452. Epub 2015 Aug 13.