Following the findings of the clinical trials in drug development, this global non-interventional cohort field study will investigate rivaroxaban under clinical practice conditions in comparison with current standard of care for patients with acute deep vein thrombosis (DVT). The main goal is to analyze long-term safety in the use of rivaroxaban in the treatment of acute DVT in routine clinical practice.
Study Type
OBSERVATIONAL
Enrollment
5,145
Patients who will be treated for an acute deep vein thrombosis (DVT) with rivaroxaban
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
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Many Locations, Austria
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Many Locations, Belgium
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Many Locations, Canada
Major bleedings defined as overt bleeding associated with: A fall in hemoglobin of ≥2 g/dL; or a transfusion of ≥2 units of packed red blood cells or whole blood; or occurrence at a critical site
Time frame: after approximately 2 years or 30 days after stop of therapy
Number of patients with symptomatic recurrent venous thromboembolic events
Time frame: after approximately 2 years or 30 days after stop of therapy
All cause mortality
Time frame: after approximately 2 years or 30 days after stop of therapy
Safety variables will be summarized using descriptive statistics based on adverse cardiac events collection
Time frame: after approximately 2 years or 30 days after stop of therapy
Number of patients with other symptomatic thromboembolic events
Time frame: after approximately 2 years or 30 days after stop of therapy
Treatment satisfaction (patient reported outcomes)
Time frame: after approximately 2 years or 30 days after stop of therapy
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Many Locations, Czechia
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Many Locations, Denmark
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Many Locations, France
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Many Locations, Germany
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Many Locations, Greece
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Many Locations, Hungary
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Many Locations, Israel
...and 11 more locations