Treatment of an Acute Deep Vein Thrombosis (DVT) With Either Rivaroxaban or Current Standard of Care Therapy
NCT ID: NCT01619007
Last Updated: 2017-01-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
5145 participants
OBSERVATIONAL
2012-06-30
2015-07-31
Brief Summary
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The main goal is to analyze long-term safety in the use of rivaroxaban in the treatment of acute DVT in routine clinical practice.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Group 1
Rivaroxaban (Xarelto, BAY59-7939)
Patients who will be treated for an acute deep vein thrombosis (DVT) with rivaroxaban
Group 2
Standard of care
Patients who will be treated for an acute deep vein thrombosis (DVT) with current standard of care comprising e.g. of initial treatment with low-molecular weight heparin or fondaparinux, followed by oral Vitamin-K antagonist for at least 3 months
Interventions
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Rivaroxaban (Xarelto, BAY59-7939)
Patients who will be treated for an acute deep vein thrombosis (DVT) with rivaroxaban
Standard of care
Patients who will be treated for an acute deep vein thrombosis (DVT) with current standard of care comprising e.g. of initial treatment with low-molecular weight heparin or fondaparinux, followed by oral Vitamin-K antagonist for at least 3 months
Eligibility Criteria
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Inclusion Criteria
* Patients \>= 18 years
* Patiebts with diagnosis of acute DVT and who have an indication for anticoagulation therapy for at least 12 weeks, who are willing to participate in this study and are available for follow-up
18 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Many Locations, , Austria
Many Locations, , Belgium
Many Locations, , Canada
Many Locations, , Czechia
Many Locations, , Denmark
Many Locations, , France
Many Locations, , Germany
Many Locations, , Greece
Many Locations, , Hungary
Many Locations, , Israel
Many Locations, , Italy
Many Locations, , Moldova
Many Locations, , Netherlands
Many Locations, , Norway
Many Locations, , Portugal
Many Locations, , Slovenia
Many Locations, , Spain
Many Locations, , Sweden
Many Locations, , Switzerland
Many Locations, , Ukraine
Many Locations, , United Kingdom
Countries
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References
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Ageno W, Mantovani LG, Haas S, Kreutz R, Monje D, Schneider J, Bugge JP, Gebel M, Turpie AGG. Patient Management Strategies and Long-Term Outcomes in Isolated Distal Deep-Vein Thrombosis versus Proximal Deep-Vein Thrombosis: Findings from XALIA. TH Open. 2019 Mar 26;3(1):e85-e93. doi: 10.1055/s-0039-1683968. eCollection 2019 Jan.
Ageno W, Mantovani LG, Haas S, Kreutz R, Monje D, Schneider J, van Eickels M, Gebel M, Zell E, Turpie AG. Safety and effectiveness of oral rivaroxaban versus standard anticoagulation for the treatment of symptomatic deep-vein thrombosis (XALIA): an international, prospective, non-interventional study. Lancet Haematol. 2016 Jan;3(1):e12-21. doi: 10.1016/S2352-3026(15)00257-4. Epub 2015 Dec 8.
Other Identifiers
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XA1102
Identifier Type: OTHER
Identifier Source: secondary_id
15915
Identifier Type: -
Identifier Source: org_study_id
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