- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02090543
BAY 59-7939 (Xarelto, SPAF), Non Interventional Studies
January 20, 2017 updated by: Bayer
Rivaroxaban Versus Vitamin K-Antagonist (VKA) in Thromboprophylaxis of Patients With Atrial Fibrillation: Patient Preference Study
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
647
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Many Locations, Germany
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Adult AF-patients, within 3 month of anticoagulation (VKA or rivaroxaban) therapy, recruited by GPs
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Group 1
300 AF patients, with at least 3 month of anticoagulation therapy with VKAs (VKA-experienced patients)
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common use, no requirements (real life situation)
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Group 2
300 AF patients, with at least 3 month of rivaroxaban therapy (rivaroxaban-experienced patients)
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common use, no requirements (real life situation)
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What is the study measuring?
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
Time Frame: Within 1-4 weeks after patient enrollement
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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
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Within 1-4 weeks after patient enrollement
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Patient relevant burden/benefit due to anticoagulation using the ACTS-questionnaire
Time Frame: At study entry
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At study entry
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2014
Primary Completion (Actual)
September 1, 2014
Study Completion (Actual)
October 1, 2014
Study Registration Dates
First Submitted
February 12, 2014
First Submitted That Met QC Criteria
March 17, 2014
First Posted (Estimate)
March 18, 2014
Study Record Updates
Last Update Posted (Estimate)
January 23, 2017
Last Update Submitted That Met QC Criteria
January 20, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17019
- OR-ITW-01-13 (Other Identifier: Company internal)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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