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| ID | Type | Description | Link |
|---|---|---|---|
| XA1214FR | Other Identifier | Company internal |
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| Name | Class |
|---|---|
| Janssen Research & Development, LLC | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rivaroxaban | 20 mg po once daily, which is also the recommended maximum dose. SmPC recommendations are to be followed for renal impairment |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rivaroxaban (Xarelto, BAY59-7939) | Drug | 20 mg po once daily, which is also the recommended maximum dose. SmPC recommendations are to be followed for renal impairment |
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| Measure | Description | Time Frame |
|---|---|---|
| Change of the Anti Clot Treatment Scale (ACTS) score at 3 months compared with baseline score | After 3 months |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
Contra indication to the use of Xarelto as described in the Summary of Product Characteristics (SmPC); key contra indications are:
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Patients more than 18 years old, with a diagnosis of acute DVT treated with VKA with issues, who switch from VKA to Xarelto
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Many Locations | France |
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| ID | Term |
|---|---|
| D020246 | Venous Thrombosis |
| D010549 | Personal Satisfaction |
| D011655 | Pulmonary Embolism |
| ID | Term |
|---|---|
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000069552 | Rivaroxaban |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
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| 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 |
| D001519 |
| Behavior |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
| D010078 |
| Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |