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| ID | Type | Description | Link |
|---|---|---|---|
| OR-ITW-01-13 | Other Identifier | Company internal |
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| Name | Class |
|---|---|
| Janssen Research & Development, LLC | INDUSTRY |
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According to recent guidelines, long-term anticoagulation is recommended for patients with atrial fibrillation (AF) and a risk profile with CHA2DS2-VASc score of 1 or more. Vitamin K antagonists(VAK) and novel oral anticoagulants such as rivaroxaban are current treatment options for AF patients with additional risk factors for stroke. Currently there are only limited information to what extend AF patients prefer one or the other treatment option based on patient relevant characteristics of novel oral anticoagulants vs. VKAs. It is also unknown which of the characteristics influences patient preference most and how this relates to a neutral comparator. Furthermore, an additional unknown factor is also how patient evaluate their current treatment and if this leads to differences among treatment with VKAs and rivaroxaban.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | 300 AF patients, with at least 3 month of anticoagulation therapy with VKAs (VKA-experienced patients) |
| |
| Group 2 | 300 AF patients, with at least 3 month of rivaroxaban therapy (rivaroxaban-experienced patients) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phenprocoumon (Marcumar) | Drug | common use, no requirements (real life situation) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| A prescription of patient preferences pattern including 5 attributes for Discrete-Choice-Experiment(DCE)-design in patients with atrial fibrillation | Attributes and values in relation to the DCE-Choice-Set. The patient will receive a "test card" with the following attributes: bridging of anticoagulation, regular anticoagulation control, limitations to eating behaviour and alcohol consumption, once vs. twice daily intake of medication, neutral comparator for quantification display of preference: distance to therapy practice | Within 1-4 weeks after patient enrollement |
| Patient relevant burden/benefit due to anticoagulation using the ACTS-questionnaire | At study entry |
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Inclusion Criteria:
A.General Criteria (Group 1and Group2):
Additional criteria for Group1 (VKA-experienced):
Additional criteria for Group2 (rivaroxaban-experienced patients):
Exclusion Criteria:
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Adult AF-patients, within 3 month of anticoagulation (VKA or rivaroxaban) therapy, recruited by GPs
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Many Locations | Germany |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D010644 | Phenprocoumon |
| D000069552 | Rivaroxaban |
| ID | Term |
|---|---|
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 |
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| Rivaroxaban (Xarelto, BAY-59 7939) |
| Drug |
common use, no requirements (real life situation) |
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
| D010078 | Oxazines |