Treatment of Venous Thromboembolism (VTE) 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 venous thoromboembolism (VTE). The main goal is to analyze long-term safety in the use of rivaroxaban in the treatment of acute VTE in routine clinical practice.

Official Title
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XALIA LEA- Xarelto for Long-term and Initial Anticoagulation in Venous Thromboembolism (VTE) in Latin America, EMEA and Asia

Conditions
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Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE)

Intervention / Treatment
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* Drug: Rivaroxaban (Xarelto, BAY59-7939)
* Drug: Recommended VTE pharmacological treatments according to international guidelines


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female or male patients, who are at >=18 years Diagnosis of acute DVT and/or PE, objectively confirmed Indication for anticoagulation therapy for at least 12 weeks Willing to participate in this study and 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 |
| --- | --- |
| Rivaroxaban<br>Patients who will be treated for an acute venous thromboembolism (VTE) with rivaroxaban. | Drug: Rivaroxaban (Xarelto, BAY59-7939)<br>* Cohort participants are classified as rivaroxaban patient, if the patient receives initial rivaroxaban VTE treatment. Dosing according to daily clinical routine<br>|
| Standard of care<br>Patients who will be treated for an acute venous thromboembolism (VTE) with current standard of care. | Drug: Recommended VTE pharmacological treatments according to international guidelines<br>* Cohort participants are classified as Standard of care patients, if the patient receives recommended VTE pharmacological treatments according to international guidelines, e.g. unfractionated heparin, LMWH, fondaparinux, VKA, if these are also approved pharmacological treatments for VTE in the respective country. Dosing according to daily clinical routine.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of major bleedings defined as overt bleeding | Major bleedings defined as overt bleeding are 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 | Up to 2 years | 
| Number of patients with symptomatic recurrent venous thromboembolic events |  | Up to 2 years | 
| All cause mortality |  | Up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse cardiovascular events | Number of cardiovascular events will be used for descriptive statistics to summarize safety variables. | Up to 2 years | 
| Number of patients with other symptomatic thromboembolic events |  | Up to 2 years | 
| Treatment satisfaction (patient reported outcomes) |  | Up to 2 years | 

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