Edoxaban for treatment of venous thromboembolism in patients with cancer: Rationale and design of the hokusai VTE-cancer study

Nick van Es, Marcello Di Nisio, Suzanne M. Bleker, Annelise Segers, Michele F. Mercuri, Lee Schwocho, Ajay Kakkar, Jeffrey I. Weitz, Jan Beyer-Westendorf, Zoltan Boda, Marc Carrier, Jaromir Chlumsky, Hervé Décousus, David Garcia, Harry Gibbs, Pieter W. Kamphuisen, Manuel Monreal, Paul Ockelford, Ingrid Pabinger, Peter VerhammeMichael A. Grosso, Harry R. Büller, Gary E. Raskob

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68 Citations (Scopus)


Direct oral anticoagulants may be effective and safe for treatment of venous thromboembolism (VTE) in cancer patients, but they have not been compared with low-molecular-weight heparin (LMWH), the current recommended treatment for these patients. The Hokusai VTEcancer study is a randomised, open-label, clinical trial to evaluate whether edoxaban, an oral factor Xa inhibitor, is non-inferior to LMWH for treatment of VTE in patients with cancer. We present the rationale and some design features of the study. One such feature is the composite primary outcome of recurrent VTE and major bleeding during a 12-month study period. These two complications occur frequently in cancer patients receiving anticoagulant treatment and have a significant impact. The evaluation beyond six months will fill the current gap in the evidence base for the long-term treatment of these patients. Based on the observation that the risk of recurrent VTE in patients with active cancer is similar to that in those with a history of cancer, the Hokusai VTE-cancer study will enrol patients if whose cancer was diagnosed within the past two years. In addition, patients with incidental VTE are eligible because their risk of recurrent VTE is similar to that in patients with symptomatic disease. The unique design features of the Hokusai VTE-cancer study should lead to enrolment of a broad spectrum of cancer patients with VTE who could benefit from oral anticoagulant treatment.

Original languageEnglish
Pages (from-to)1268-1276
Number of pages9
JournalThrombosis and Haemostasis
Issue number6
Publication statusPublished - Dec 2015
Externally publishedYes


  • Anticoagulant drugs
  • Cancer
  • Clinical trial
  • Edoxaban
  • Venous thromboembolism

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