check_circleStudy Completed

Atrial fibrillation

Bayer Identifier:

17019

ClinicalTrials.gov Identifier:

NCT02090543

EudraCT Number:

Not Available

EU CT Number:

Not Available
BAY 59-7939 (Xarelto, SPAF), Non Interventional Studies

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.

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • 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.

  • - participation in any other clinical or observational study over the last 3 month

Trial summary

Enrollment Goal
647
Trial Dates
January 2014 - October 2014
Phase
N/A
Could I Receive a placebo
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Germany

Primary Outcome

  • 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
    date_rangeTime Frame:
    Within 1-4 weeks after patient enrollement
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    Safety Issue:
    No
  • Patient relevant burden/benefit due to anticoagulation using the ACTS-questionnaire
    date_rangeTime Frame:
    At study entry
    enhanced_encryption
    Safety Issue:
    No

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
N/A

Additional Information

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