Trial Condition(s):
Atrial Fibrillation
BAY 59-7939 (Xarelto, SPAF), Non Interventional Studies
Bayer Identifier:
17019
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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.
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Investigative Site Many Locations, Germany | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Rivaroxaban versus Vitamin K-Antagonist (VKA) in Thromboprophylaxis of Patients with Atrial Fibrillation: Patient Preference Study
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
2
Primary Outcome
- A prescription of patient preferences pattern including 5 attributes for Discrete-Choice-Experiment(DCE)-design in patients with atrial fibrillationAttributes 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 practiceTimeframe: Within 1-4 weeks after patient enrollement
- Patient relevant burden/benefit due to anticoagulation using the ACTS-questionnaireTimeframe: At study entry
Additional Information
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