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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02090543
Recruitment Status : Completed
First Posted : March 18, 2014
Last Update Posted : January 23, 2017
Sponsor:
Collaborator:
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Bayer

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Atrial Fibrillation Drug: Phenprocoumon (Marcumar) Drug: Rivaroxaban (Xarelto, BAY-59 7939)

Study Design
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Study Type : Observational
Actual Enrollment : 647 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Rivaroxaban Versus Vitamin K-Antagonist (VKA) in Thromboprophylaxis of Patients With Atrial Fibrillation: Patient Preference Study
Study Start Date : January 2014
Actual Primary Completion Date : September 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Rivaroxaban

Groups and Cohorts
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Group/Cohort Intervention/treatment
Group 1
300 AF patients, with at least 3 month of anticoagulation therapy with VKAs (VKA-experienced patients)
 Drug: Phenprocoumon (Marcumar)
common use, no requirements (real life situation)
Group 2
300 AF patients, with at least 3 month of rivaroxaban therapy (rivaroxaban-experienced patients)
 Drug: Rivaroxaban (Xarelto, BAY-59 7939)
common use, no requirements (real life situation)


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
    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

  2. Patient relevant burden/benefit due to anticoagulation using the ACTS-questionnaire [ Time Frame: At study entry ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02090543


Locations
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Germany
Many Locations, Germany
Sponsors and Collaborators
Bayer
Janssen Research & Development, LLC
Investigators
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Study Director: Bayer Study Director Bayer
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02090543    
Other Study ID Numbers: 17019
OR-ITW-01-13 ( Other Identifier: Company internal )
First Posted: March 18, 2014    Key Record Dates
Last Update Posted: January 23, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
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Arrhythmias, Cardiac
Atrial Fibrillation
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Rivaroxaban
Phenprocoumon
 Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants