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Blood, 15 September 2008, Vol. 112, No. 6, pp. 2242-2247. Prepublished online as a Blood First Edition Paper on July 11, 2008; DOI 10.1182/blood-2008-05-160143. This Article Full Text Full Text (PDF) Supplemental Appendix All Versions of this Article: blood-2008-05-160143v1 112/6/2242    most recent Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Rights and Permissions Citing Articles Citing Articles via HighWire Citing Articles via CrossRef Citing Articles via Google Scholar Google Scholar Articles by Buller, H. R. Articles by Segers, A. Search for Related Content PubMed PubMed Citation Articles by Buller, H. R. Articles by Segers, A. Related Collections Hemostasis, Thrombosis, and Vascular Biology Free Research Articles Clinical Trials and Observations Social Bookmarking                   What's this?  Previous Article  |  Table of Contents  |  Next Article  CLINICAL TRIALS AND OBSERVATIONS A dose-ranging study evaluating once-daily oral administration of the factor Xa inhibitor rivaroxaban in the treatment of patients with acute symptomatic deep vein thrombosis: the Einstein–DVT Dose-Ranging Study Harry R. Buller1, Anthonie W. A. Lensing1,2, Martin H. Prins3, Giancarlo Agnelli4, Alexander Cohen5, Alexander S. Gallus6, Frank Misselwitz2, Gary Raskob7, Sebastian Schellong8, Annelise Segers1,9, on behalf of the Einstein–DVT Dose-Ranging Study investigators 1 Department of Vascular Medicine, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands; 2 BayerHealthCare AG, Wuppertal, Germany; 3 Department of Epidemiology, Care and Public Health Research Institute, University of Maastricht and Department of Clinical Epidemiology and Medical Technology Assessment, Academic Hospital Maastricht, Maastricht, The Netherlands; 4 Institute of Internal and Vascular Medicine, University of Perugia, Perugia, Italy; 5 Kings College School of Medicine & Dentistry, London, United Kingdom; 6 Department of Hematology, Flinders Medical Center, Bedford Park, Australia; 7 College of Public Health, University of Oklahoma, Oklahoma City; 8 Universitaetsklinikum Carl Gustav Carus, Dresden, Germany; and 9 International Clinical Trial Organization and Management, Amsterdam, The Netherlands We performed a randomized dose-ranging study, double-blind for rivaroxaban doses and open-label for the comparator (low-molecular-weight heparin followed by vitamin K antagonists) to assess the optimal dose of rivaroxaban for the treatment of deep vein thrombosis. A total of 543 patients with acute deep-venous thrombosis received rivaroxaban 20, 30, or 40 mg once daily or comparator. Treatment lasted for 84 days. The primary efficacy outcome was the 3-month incidence of the composite of symptomatic venous thromboembolic complications and asymptomatic deterioration in thrombotic burden as assessed by comparison of ultrasound and perfusion lung scanning at day 84 with baseline. The main safety outcome was the composite of major bleeding and clinically relevant nonmajor bleeding. A total of 449 (83%) of the 543 patients could be included in the per-protocol population. The primary efficacy outcome occurred in 6.1%, 5.4%, and 6.6% of the rivaroxaban 20-, 30-, and 40-mg treatment groups, respectively, and in 9.9% of those receiving standard therapy. The main safety outcome occurred in 5.9%, 6.0%, and 2.2% of the rivaroxaban 20-, 30-, and 40-mg treatment groups, respectively, and in 8.8% of those receiving standard therapy. These results with simple fixed-dose oral regimens justify phase 3 evaluations (www.ClinicalTrials.gov no.NCT00395772 [ClinicalTrials.gov] ). CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    What's this? This article has been cited by other articles: M. N. Levine New Antithrombotic Drugs: Potential for Use in Oncology J. Clin. Oncol., October 10, 2009; 27(29): 4912 - 4918. [Abstract] [Full Text] [PDF] Oral Treatment for Deep Venous Thrombosis Journal Watch Oncology and Hematology, October 21, 2008; 2008(1021): 2 - 2. [Full Text]

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