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

Jeffrey I. Weitz; Rupert Bauersachs; Jan Beyer-Westendorf; Henri Bounameaux; Timothy A. Brighton; Alexander T. Cohen; Bruce L. Davidson; Gerlind Holberg; Ajay Kakkar; Anthonie W. A. Lensing; Martin Prins; Lloyd Haskell; Bonno van Bellen; Peter Verhamme; Philip S. Wells; Paolo Prandoni; the EINSTEIN CHOICE Investigators; on behalf of

doi:10.1160/TH15-02-0131

Thrombosis and Haemostasis, Inhaltsverzeichnis

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

¹Thrombosis & Atherosclerosis Research Institute and McMaster University, Hamilton, Ontario, Canada

,

Rupert Bauersachs

²Vascular Medicine, Klinikum Darmstadt, Darmstadt, Germany

,

Jan Beyer-Westendorf

³University Hospital “Carl-Gustav Carus”, Department of Vascular Medicine, Technische Universität Dresden, Germany

,

Henri Bounameaux

⁴Division of Angiology and Hemostasis, University Hospitals of Geneva and Faculty of Medicine, Geneva, Switzerland

,

Timothy A. Brighton

⁵Department of Haematology, Prince of Wales Hospital, Sydney, New South Wales, Australia

,

Alexander T. Cohen

⁶Department of Haematological Medicine, Guys and St Thomas’ Hospitals, King’s College Hospital, London, UK

,

Bruce L. Davidson

⁷University of Washington School of Medicine, Seattle, Washington, USA

,

Gerlind Holberg

⁸Bayer HealthCare AG, Leverkusen, Germany

,

Ajay Kakkar

⁹Thrombosis Research Institute, London and University College London, UK

,

Anthonie W. A. Lensing

⁸Bayer HealthCare AG, Leverkusen, Germany

,

Martin Prins

¹⁰Maastricht University Medical Center, Maastricht, The Netherlands

,

Lloyd Haskell

¹¹Janssen Research & Development, Raritan, New Jersey, USA

,

Bonno van Bellen

¹²Hospital Beneficência Portuguesa, São Paulo, Brazil

,

Peter Verhamme

¹³Vascular Medicine and Hemostasis, University of Leuven, Belgium

,

Philip S. Wells

¹⁴Department of Medicine, University of Ottawa and the Ottawa Hospital Research Institute, Ontario, Canada

,

Paolo Prandoni

¹⁵Department of Cardiothoracic & Vascular Sciences, Thromboembolism Unit, University of Padua, Italy

,

the EINSTEIN CHOICE Investigators

› Institutsangaben

Abstract

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

Volltext

Referenzen

References
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