Treatment of an Acute Deep Vein Thrombosis (DVT) With Either Rivaroxaban or Current Standard of Care Therapy

Study Overview
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Brief Summary
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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.

Official Title
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Xarelto® for Long-term and Initial Anticoagulation in Venous Thromboembolism (VTE)

Conditions
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Deep Vein Thrombosis, Venous Thrombosis

Intervention / Treatment
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* Drug: Rivaroxaban (Xarelto, BAY59-7939)
* Drug: Standard of care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female and male patients 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 Exclusion Criteria: Exclusion criteria must be read in conjunction with the local product information.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br> | Drug: Rivaroxaban (Xarelto, BAY59-7939)<br>* Patients who will be treated for an acute deep vein thrombosis (DVT) with rivaroxaban<br>|
| Group 2<br> | Drug: Standard of care<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | after approximately 2 years or 30 days after stop of therapy | 
| Number of patients with symptomatic recurrent venous thromboembolic events |  | after approximately 2 years or 30 days after stop of therapy | 
| All cause mortality |  | after approximately 2 years or 30 days after stop of therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety variables will be summarized using descriptive statistics based on adverse cardiac events collection |  | after approximately 2 years or 30 days after stop of therapy | 
| Number of patients with other symptomatic thromboembolic events |  | after approximately 2 years or 30 days after stop of therapy | 
| Treatment satisfaction (patient reported outcomes) |  | after approximately 2 years or 30 days after stop of therapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Treatment of Venous Thromboembolism, Thromboembolism, Venous Thromboembolism, Embolism and Thrombosis, Vascular Diseases, Cardiovascular Diseases, Thrombosis