BAY 59-7939 (Xarelto, SPAF), Non Interventional Studies

Study Overview
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Brief Summary
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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.

Official Title
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Rivaroxaban Versus Vitamin K-Antagonist (VKA) in Thromboprophylaxis of Patients With Atrial Fibrillation: Patient Preference Study

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Drug: Phenprocoumon (Marcumar)
* Drug: Rivaroxaban (Xarelto, BAY-59 7939)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A.General Criteria (Group 1and Group2): diagnosed non-valvular AF older than 18 years general capability and willingness to perform a structured patient interview in German no participation in any other clinical or observational study over the last 3 month Additional criteria for Group1 (VKA-experienced): active VKA-therapy for at least 3 month without significant interruptions in case of perioperative interruption VKA treatment should not have been hold for more than two weeks. Additional criteria for Group2 (rivaroxaban-experienced patients): active rivaroxaban-therapy for at least 3 month without significant interruptions in case of perioperative interruption VKA treatment should not have been hold for more than two weeks. Exclusion Criteria: participation in any other clinical or observational study over the last 3 month

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>300 AF patients, with at least 3 month of anticoagulation therapy with VKAs (VKA-experienced patients) | Drug: Phenprocoumon (Marcumar)<br>* common use, no requirements (real life situation)<br>|
| Group 2<br>300 AF patients, with at least 3 month of rivaroxaban therapy (rivaroxaban-experienced patients) | Drug: Rivaroxaban (Xarelto, BAY-59 7939)<br>* common use, no requirements (real life situation)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |