Satisfaction/Quality of Life With Rivaroxaban in DVT (Deep Venous Thrombosis) Indication

Study Overview
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Brief Summary
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National, multicenter, prospective, observational, non-interventional study. The objective is to determine if the switch from Vitamin K antagonists (VKA) to Xarelto in subjects treated with VKA with issues in deep venous thrombosis (DVT), and prevention of recurrent DVT and pulmonary embolism (PE) is associated with an improvement of the treatment satisfaction after 3 months. The treatment satisfaction will be measured by the Anti Clot Treatment Scale (ACTS) score.

Official Title
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Satisfaction and Quality of Life in Patients With a Diagnosis of DVT (Deep Venous Thrombosis) Who Take Rivaroxaban

Conditions
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Venous Thrombosis

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female or male subject ≥ 18 years of age, With a diagnosis of acute DVT treated with VKA with issues for at least the 4 previous weeks (issues are assessed on medical judgment) Who intends to start rivaroxaban for treatment of deep vein thrombosis (DVT), and prevention of recurrent DVT and pulmonary embolism (PE) following an acute DVT With anticoagulation therapy planned for at least 3 months Exclusion Criteria: Contra indication to the use of Xarelto as described in the Summary of Product Characteristics (SmPC); key contra indications are: Hypersensitivity to the active substance or to any of the excipients listed in SmPC section 6.1. Lesion or condition at significant risk of major bleeding Concomitant treatment with any other anticoagulant agent Clinically significant active bleeding Hepatic disease associated with coagulopathy and clinically relevant bleeding risk including cirrhotic patients with Child Pugh B and C Pregnancy and breast feeding

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>20 mg po once daily, which is also the recommended maximum dose. SmPC recommendations are to be followed for renal impairment | Drug: Rivaroxaban (Xarelto, BAY59-7939)<br>* 20 mg po once daily, which is also the recommended maximum dose. SmPC recommendations are to be followed for renal impairment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of the Anti Clot Treatment Scale (ACTS) score at 3 months compared with baseline score |  | After 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of ACTS score after 1 and 6 months of treatment |  | After 1 and 6 months | 
| Continuation rate at 1, 3 and 6 months |  | After 1, 3 and 6 months | 
| Change of SF36 score at 1, 3 and 6 months (health related quality of life determined by SF36 questionnaire) |  | After 1, 3 and 6 months | 
| Physician's satisfaction at 1, 3 and 6 months assessed by a 5-point Likert scale response (very satisfied, satisfied, neutral, unsatisfied or very unsatisfied) |  | After 1, 3 and 6 months | 
| Patient's compliance with VKA treatment at baseline and with Xarelto treatment at 1, 3 and 6 months assessed by the investigator as good (≥80%), average (50-80%) or poor (<50%) |  | After 1, 3 and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SF36 questionnaire, Anti Clot Treatment Scale, Satisfaction, Quality of Life, Rivaroxaban, Prevention & control, Pulmonary embolism