Xarelto Regulatory Post-Marketing Surveillance

Study Overview
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Brief Summary
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This study is to identify the following problems and questions with respect to the safety and effectiveness of Xarelto in comparison with other pharmacologic agents in the prophylaxis of venous thromboembolism (VTE) in a large sample of patients who undergo elective total hip replacement (THR) or total knee replacement (TKR) in the real-life conditions in its registered indication(s) as required by Korean Food and Drug Administration (KFDA). Known and unknown adverse reactions, especially serious adverse reactions Incidence of adverse reactions under the routine drug use Factors that may affect the safety of the drug Factors that may affect the effectiveness of the drug Other safety information related to overuse, drug interaction and laboratory abnormalities Other adverse reactions

Official Title
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Xarelto® Regulatory Post-Marketing Surveillance

Conditions
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Venous Thromboembolism

Intervention / Treatment
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* Drug: Rivaroxaban (Xarelto, BAY59-7939)
* Drug: Pharmacologic agents (e.g. LMWH/VKA/Fondaparinux/Aspirin and etc.)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female and male patients >/= 18 years of age who will undergo elective total hip replacement or total knee replacement and receive Xarelto or other pharmacologic standard of care Venous Thromboembolism (VTE) prophylaxis, and who consent to participate in the study Exclusion Criteria: Patients with hypersensitivity to any pharmacologic VTE prophylaxis treatment Patients with clinically significant active bleeding (e.g., intracranial bleeding, gastrointestinal bleeding) Patients with significant hepatic disease which is associated with coagulopathy leading to a clinically relevant bleeding risk Pregnant or lactating women Patients with hereditary problems of lactose or galactose intolerance (e.g., the Lapp lactase deficiency or glucose-galactose malabsorption)

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>* Daily dose, a treatment duration of 5 weeks for patients undergoing major hip surgery and a treatment duration of 2 weeks for patients undergoing major knee surgery are recommended<br>|
| Group 2<br> | Drug: Pharmacologic agents (e.g. LMWH/VKA/Fondaparinux/Aspirin and etc.)<br>* Daily dose, dosage frequency and duration will be decided by physicians<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse event collection |  | From the start of signed consent to 4 weeks after discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of treatment |  | Whole treatment period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TKR (Total Knee Replacement), THR (Total Hip Replacement), VTE (Venous Thromboembolism), LMWH (Low Molecular Weight Heparin), VKA (Vitamin K antagonist)