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Thromb Haemost 2015; 114(03): 645-650
DOI: 10.1160/TH15-02-0131
Trial Protocol Design Paper
Schattauer GmbH

Two doses of rivaroxaban versus aspirin for prevention of recurrent venous thromboembolism

Rationale for and design of the EINSTEIN CHOICE study
Jeffrey I. Weitz
1   Thrombosis & Atherosclerosis Research Institute and McMaster University, Hamilton, Ontario, Canada
,
Rupert Bauersachs
2   Vascular Medicine, Klinikum Darmstadt, Darmstadt, Germany
,
Jan Beyer-Westendorf
3   University Hospital “Carl-Gustav Carus”, Department of Vascular Medicine, Technische Universität Dresden, Germany
,
Henri Bounameaux
4   Division of Angiology and Hemostasis, University Hospitals of Geneva and Faculty of Medicine, Geneva, Switzerland
,
Timothy A. Brighton
5   Department of Haematology, Prince of Wales Hospital, Sydney, New South Wales, Australia
,
Alexander T. Cohen
6   Department of Haematological Medicine, Guys and St Thomas’ Hospitals, King’s College Hospital, London, UK
,
Bruce L. Davidson
7   University of Washington School of Medicine, Seattle, Washington, USA
,
Gerlind Holberg
8   Bayer HealthCare AG, Leverkusen, Germany
,
Ajay Kakkar
9   Thrombosis Research Institute, London and University College London, UK
,
Anthonie W. A. Lensing
8   Bayer HealthCare AG, Leverkusen, Germany
,
Martin Prins
10   Maastricht University Medical Center, Maastricht, The Netherlands
,
Lloyd Haskell
11   Janssen Research & Development, Raritan, New Jersey, USA
,
Bonno van Bellen
12   Hospital Beneficência Portuguesa, São Paulo, Brazil
,
Peter Verhamme
13   Vascular Medicine and Hemostasis, University of Leuven, Belgium
,
Philip S. Wells
14   Department of Medicine, University of Ottawa and the Ottawa Hospital Research Institute, Ontario, Canada
,
Paolo Prandoni
15   Department of Cardiothoracic & Vascular Sciences, Thromboembolism Unit, University of Padua, Italy
,
the EINSTEIN CHOICE Investigators › Author Affiliations
Further Information

Publication History

Received: 18 February 2015

Accepted after minor revision: 10 April 2015

Publication Date:
01 December 2017 (online)

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Summary

Patients with unprovoked venous thromboembolism (VTE) are at high risk for recurrence. Although rivaroxaban is effective for extended VTE treatment at a dose of 20 mg once daily, use of the 10 mg dose may further improve its benefit-to-risk ratio. Low-dose aspirin also reduces rates of recurrent VTE, but has not been compared with anticoagulant therapy. The EINSTEIN CHOICE study is a multicentre, randomised, double-blind, active-controlled, event-driven study comparing the efficacy and safety of two once daily doses of rivaroxaban (20 and 10 mg) with aspirin (100 mg daily) for the prevention of recurrent VTE in patients who completed 6–12 months of anticoagulant therapy for their index acute VTE event. All treatments will be given for 12 months. The primary efficacy objective is to determine whether both doses of rivaroxaban are superior to aspirin for the prevention of symptomatic recurrent VTE, while the principal safety outcome is the incidence of major bleeding. The trial is anticipated to enrol 2,850 patients from 230 sites in 31 countries over a period of 27 months. In conclusion, the EINSTEIN CHOICE study will provide new insights into the optimal antithrombotic strategy for extended VTE treatment by comparing two doses of rivaroxaban with aspirin (clinicaltrials.gov NCT02064439).

Keywords

Venous thrombosis - deep-vein thrombosis - pulmonary embolism - anti-platelet agents - prevention

 

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