An observational study in Deep Vein Thrombosis and Venous Thrombosis, sponsored by Bayer. Completed at 21 sites in 21 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-01-23.
Sponsored by Bayer · Observational
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.
1,508 studies on the registry are indexed under Thrombosis; 239 are open to participants now.
This study's enrollment of 5,145 is above the median of 213 across 588 observational studies indexed under Thrombosis.
Browse Thrombosis studies →Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.
Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.
Counted across the registry records on this site, refreshed daily.
In- and outpatients in sites participating in the study
Exclusion Criteria:
Drug: Rivaroxaban (Xarelto, BAY59-7939)
Drug: Standard of care
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
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
This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.
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