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Thromb Haemost 2015; 114(06): 1268-1276
DOI: 10.1160/TH15-06-0452
Stroke, Systemic or Venous Thromboembolism
Schattauer GmbH

Edoxaban for treatment of venous thromboembolism in patients with cancer

Rationale and design of the Hokusai VTE-cancer study
Nick van Es
1   Department of Vascular Medicine, Academic Medical Center, Amsterdam, The Netherlands
,
Marcello Di Nisio
2   Department of Medical, Oral and Biotechnological Sciences, G. D’Annunzio University, Chieti, Italy
,
Suzanne M. Bleker
1   Department of Vascular Medicine, Academic Medical Center, Amsterdam, The Netherlands
,
Annelise Segers
3   ITREAS, Amsterdam, The Netherlands
,
Michele F. Mercuri
4   Clinical Development, Daiichi Sankyo Pharma Development, Edison, New Jersey, USA
,
Lee Schwocho
4   Clinical Development, Daiichi Sankyo Pharma Development, Edison, New Jersey, USA
,
Ajay Kakkar
5   Thrombosis Research Institute, London and University College London, UK
,
Jeffrey I. Weitz
6   Thrombosis & Atherosclerosis Research Institute and McMaster University, Hamilton, Ontario, Canada
,
Jan Beyer-Westendorf
7   University Hospital “Carl-Gustav Carus”, Department of Vascular Medicine, Technische Universität Dresden, Germany
,
Zoltan Boda
8   Department of Medicine, University of Debrecen, Debrecen, Hungary
,
Marc Carrier
9   Department of Medicine, The Ottawa Hospital Research Institute, University of Ottawa, Ontario, Canada
,
Jaromir Chlumsky
10   Department of Medicine, 2nd Faculty Hospital, Charles University, Prague, Czech Republic
,
Hervé Décousus
11   Service Médecine Vasculaire et Thérapeutique, Centre Hospitalier Universitaire de Saint-Etienne, Hôpital Nord, Saint-Etienne, France
,
David Garcia
12   Division of Hematology, University of Washington, Seattle, Washington, USA
,
Harry Gibbs
13   Department of General Medicine, The Alfred Hospital, Prahran, Victoria, Australia
,
Pieter W. Kamphuisen
14   Department of Vascular Medicine, University Medical Center Groningen, Groningen, The Netherlands
,
Manuel Monreal
15   Department of Internal Medicine, Hospital Universitari Germans Trias i Pujol, Carretera del Canyet, Badalona, Spain
,
Paul Ockelford
16   Department of Haematology, Auckland City Hospital, Auckland, New Zealand
,
Ingrid Pabinger
17   Clinical Division of Haematology and Haemostaseology, Department of Medicine I, Medical University of Vienna, Vienna, Austria
,
Peter Verhamme
18   Department of Vascular Medicine and Hemostasis, University of Leuven, Leuven, Belgium
,
Michael A. Grosso
4   Clinical Development, Daiichi Sankyo Pharma Development, Edison, New Jersey, USA
,
Harry R. Büller
1   Department of Vascular Medicine, Academic Medical Center, Amsterdam, The Netherlands
,
Gary E. Raskob
19   College of Public Health, University of Oklahoma Health Sciences Centre, Oklahoma City, Oklahoma, USA
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Publikationsverlauf

Received: 03. Juni 2015

Accepted after major revision: 03. Juli 2015

Publikationsdatum:
30. November 2017 (online)

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Summary

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 VTE-cancer 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.

Keywords

Anticoagulant drugs - clinical trial - edoxaban - cancer - venous thromboembolism

 

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