Treatment of Venous Thromboembolism (VTE) With Either Rivaroxaban or Current Standard of Care Therapy (XALIA LEA)
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|ClinicalTrials.gov Identifier: NCT02210819|
Recruitment Status : Completed
First Posted : August 7, 2014
Last Update Posted : March 20, 2018
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.
|Condition or disease||Intervention/treatment|
|Deep Vein Thrombosis (DVT) and / or Pulmonary Embolism (PE)||Drug: Rivaroxaban (Xarelto, BAY59-7939) Drug: Recommended VTE pharmacological treatments according to international guidelines|
|Study Type :||Observational|
|Actual Enrollment :||1987 participants|
|Official Title:||XALIA LEA- Xarelto for Long-term and Initial Anticoagulation in Venous Thromboembolism (VTE) in Latin America, EMEA and Asia|
|Actual Study Start Date :||June 27, 2014|
|Primary Completion Date :||November 3, 2016|
|Study Completion Date :||January 20, 2017|
Patients who will be treated for an acute venous thromboembolism (VTE) with rivaroxaban.
Drug: Rivaroxaban (Xarelto, BAY59-7939)
Cohort participants are classified as "rivaroxaban" patient, if the patient receives initial rivaroxaban VTE treatment. Dosing according to daily clinical routine
Standard of care
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
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.
- Number of major bleedings defined as overt bleeding [ Time Frame: Up to 2 years ]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
- Number of patients with symptomatic recurrent venous thromboembolic events [ Time Frame: Up to 2 years ]
- All cause mortality [ Time Frame: Up to 2 years ]
- Number of adverse cardiovascular events [ Time Frame: Up to 2 years ]Number of cardiovascular events will be used for descriptive statistics to summarize safety variables.
- Number of patients with other symptomatic thromboembolic events [ Time Frame: Up to 2 years ]
- Treatment satisfaction (patient reported outcomes) [ Time Frame: Up to 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02210819
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|Study Director:||Bayer Study Director||Bayer|