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| ID | Type | Description | Link |
|---|---|---|---|
| XA1213FR | Other Identifier | Company internal |
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| Name | Class |
|---|---|
| Janssen Scientific Affairs, 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 for stroke prevention in non valvular atrial fibrillation 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 |
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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. In subjects with moderate creatinine clearance (30-49 ml/min), the dose 15 mg once daily is recommended. |
| 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 non-valvular atrial fibrillation, treated to prevent stroke or non-central nervous system systemic embolism, who switch from VKA to Xarelto due to issues with VKA
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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 |
|---|---|
| D001281 | Atrial Fibrillation |
| D010549 | Personal Satisfaction |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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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 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
| D010078 |
| Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |