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

Atrial Fibrillation Clinical Trial

Official title:

Rivaroxaban Versus Vitamin K-Antagonist (VKA) in Thromboprophylaxis of Patients With Atrial Fibrillation: Patient Preference Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02090543
• Other study ID #: 17019
• Secondary ID: OR-ITW-01-13
• Status: Completed
• Phase: N/A
• First received: February 12, 2014
• Last updated: January 20, 2017
• Start date: January 2014
• Est. completion date: October 2014

Study information

• Verified date: January 2017
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 647
• Est. completion date: October 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• Phenprocoumon (Marcumar)
common use, no requirements (real life situation)
• Rivaroxaban (Xarelto, BAY-59 7939)
common use, no requirements (real life situation)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Janssen Research & Development, LLC

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Within 1-4 weeks after patient enrollement
Primary	Patient relevant burden/benefit due to anticoagulation using the ACTS-questionnaire		At study entry

External Links

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