Document Detail

Treatment of proximal deep-vein thrombosis with the oral direct factor Xa inhibitor rivaroxaban (BAY 59-7939): the ODIXa-DVT (Oral Direct Factor Xa Inhibitor BAY 59-7939 in Patients With Acute Symptomatic Deep-Vein Thrombosis) study.
MedLine Citation:
PMID:  17576867     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: An effective and safe oral anticoagulant that needs no monitoring for dose adjustment is urgently needed for the treatment of diseases that require long-term anticoagulation. Rivaroxaban (BAY 59-7939) is an oral direct factor Xa inhibitor currently under clinical development. METHODS AND RESULTS: This randomized, parallel-group phase II trial in patients with proximal deep-vein thrombosis explored the efficacy and safety of rivaroxaban 10, 20, or 30 mg BID or 40 mg once daily compared with enoxaparin 1 mg/kg BID followed by vitamin K antagonist. Each treatment was administered for 12 weeks. The primary efficacy end point was an improvement in thrombotic burden at day 21 (assessed by quantitative compression ultrasonography; > or = 4-point improvement in thrombus score) without recurrent symptomatic venous thromboembolism or venous thromboembolism-related death. The primary safety end point was major bleeding during 12 weeks of treatment. Outcomes were adjudicated centrally without knowledge of treatment allocation. The primary efficacy end point was achieved in 53 (53.0%) of 100, 58 (59.2%) of 98, 62 (56.9%) of 109, and 49 (43.8%) of 112 patients receiving rivaroxaban 10, 20, or 30 mg BID or 40 mg once daily, respectively, compared with 50 (45.9%) of 109 patients treated with enoxaparin/vitamin K antagonist. There was no significant trend in the dose-response relationship between rivaroxaban BID and the primary efficacy end point (P=0.67). Major bleeding was observed in 1.7%, 1.7%, 3.3%, and 1.7% of patients receiving rivaroxaban 10, 20, or 30 mg BID or 40 mg once daily, respectively. There were no major bleeding events with enoxaparin/vitamin K antagonist. CONCLUSIONS: Results of this proof-of-concept and dose-finding study support phase III evaluation of the orally active direct factor Xa inhibitor rivaroxaban, because efficacy and safety were apparent in the treatment of proximal deep-vein thrombosis across a 3-fold range of fixed daily dosing.
Giancarlo Agnelli; Alexander Gallus; Samuel Z Goldhaber; Sylvia Haas; Menno V Huisman; Russel D Hull; Ajay K Kakkar; Frank Misselwitz; Sebastian Schellong;
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Publication Detail:
Type:  Clinical Trial, Phase II; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2007-06-18
Journal Detail:
Title:  Circulation     Volume:  116     ISSN:  1524-4539     ISO Abbreviation:  Circulation     Publication Date:  2007 Jul 
Date Detail:
Created Date:  2007-07-10     Completed Date:  2007-08-17     Revised Date:  2009-02-10    
Medline Journal Info:
Nlm Unique ID:  0147763     Medline TA:  Circulation     Country:  United States    
Other Details:
Languages:  eng     Pagination:  180-7     Citation Subset:  AIM; IM    
Division of Internal and Cardiovascular Medicine, University of Perugia, Ospedale S. Maria della Misericordia, Perugia, Italy.
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MeSH Terms
Administration, Oral
Anticoagulants / therapeutic use
Factor Xa / antagonists & inhibitors*
Heparin / therapeutic use
Morpholines / administration & dosage,  therapeutic use*,  toxicity
Patient Selection
Pulmonary Embolism / diagnosis
Thiophenes / administration & dosage,  therapeutic use*,  toxicity
Thrombosis / drug therapy*
Reg. No./Substance:
0/Anticoagulants; 0/Morpholines; 0/Thiophenes; 0/rivaroxaban; 9005-49-6/Heparin; EC Xa
Comment In:
Circulation. 2007 Jul 10;116(2):131-3   [PMID:  17576860 ]

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