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CompletedNCT02090543Updated Jan 23, 2017

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

An observational study in Atrial Fibrillation, sponsored by Bayer. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-01-23.

Sponsored by Bayer · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
647
Ages
18 Years and older
Sex
All
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Study summary

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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Conditions studied

  • Atrial Fibrillation

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03

In context

Atrial Fibrillation

3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.

This study's enrollment of 647 is above the median of 300 across 1,363 observational studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.

Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult AF-patients, within 3 month of anticoagulation (VKA or rivaroxaban) therapy, recruited by GPs

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

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
647 participants (actual)

Groups and cohorts

  • Group 1

    300 AF patients, with at least 3 month of anticoagulation therapy with VKAs (VKA-experienced patients)

    Drug: Phenprocoumon (Marcumar)

  • Group 2

    300 AF patients, with at least 3 month of rivaroxaban therapy (rivaroxaban-experienced patients)

    Drug: Rivaroxaban (Xarelto, BAY-59 7939)

Interventions

  • DrugPhenprocoumon (Marcumar)

    common use, no requirements (real life situation)

  • DrugRivaroxaban (Xarelto, BAY-59 7939)

    common use, no requirements (real life situation)

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What researchers measure

Primary outcomes

  1. 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

    Time frame: Within 1-4 weeks after patient enrollement

  2. Patient relevant burden/benefit due to anticoagulation using the ACTS-questionnaire

    Time frame: At study entry

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Study locations

1 site
  • Many Locations, Germany
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 23, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02090543
Lead sponsor
Bayer
Collaborators
Janssen Research & Development, LLC
Responsible party
Sponsor
First posted
Mar 18, 2014
Start date
Jan 2014
Primary completion
Sep 2014
Completion
Oct 2014
Last update
Jan 23, 2017

Study contacts

Bayer Study Director
study director · Bayer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

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