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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Bayer
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT02090543
First received: February 12, 2014
Last updated: August 4, 2014
Last verified: August 2014
  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.


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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Rivaroxaban Versus Vitamin K-Antagonist (VKA) in Thromboprophylaxis of Patients With Atrial Fibrillation: Patient Preference Study

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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

  • Patient relevant burden/benefit due to anticoagulation using the ACTS-questionnaire [ Time Frame: At study entry ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: January 2014
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02090543

Contacts
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com

Locations
Germany
Recruiting
Many Locations, Germany
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02090543     History of Changes
Other Study ID Numbers: 17019, OR-ITW-01-13
Study First Received: February 12, 2014
Last Updated: August 4, 2014
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Rivaroxaban
Phenprocoumon
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 20, 2014