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Cancer Venous Thromboembolism (VTE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2016 by Daiichi Sankyo Inc.
Information provided by (Responsible Party):
Daiichi Sankyo Inc. Identifier:
First received: February 25, 2014
Last updated: October 14, 2016
Last verified: October 2016

February 25, 2014
October 14, 2016
March 2015
December 2017   (Final data collection date for primary outcome measure)
  • incidence of recurrent VTE at end of study [ Time Frame: 6 months ]
    primary efficacy outcome is incidence of recurrent VTE at end of study
  • incidence of of clinically relevant bleeding while on treatment [ Time Frame: 6 months ]
    primary safety outcome is incidence of clinically relevant bleeding while on treatment
Same as current
Complete list of historical versions of study NCT02073682 on Archive Site
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Cancer Venous Thromboembolism (VTE)
Not Provided
Edoxaban will be similar to dalteparin in preventing recurrence of acute VTE following an initial index event in cancer subjects.
Not Provided
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Venous Thromboembolism (VTE)
  • Deep Vein Thrombosis (DVT)
  • Pulmonary Embolism (PE)
  • Cancer
  • Drug: edoxaban
  • Drug: Dalteparin
  • Experimental: edoxaban group
    Intervention: Drug: edoxaban
  • Active Comparator: dalteparin group
    Intervention: Drug: Dalteparin
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, Décousus H, Garcia D, Gibbs H, Kamphuisen PW, Monreal M, Ockelford P, Pabinger I, Verhamme P, Grosso MA, Büller 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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 2017
December 2017   (Final data collection date for primary outcome measure)

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;
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact: Lee Schwocho, PhD 7325905019
Contact: Claire McIver +353 18195409
United States,   Belgium,   France,   Hungary,   Italy,   Netherlands
2014-004708-30 ( EudraCT Number )
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Daiichi Sankyo Inc.
Daiichi Sankyo Inc.
Not Provided
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Daiichi Sankyo Inc.
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP