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

Completed

• Conditions: Atrial Fibrillation
• Interventions: Drug: Phenprocoumon (Marcumar); Drug: Rivaroxaban (Xarelto, BAY-59 7939)

• Registration Number: NCT02090543
• Lead Sponsor: Bayer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-02-12
• Study First Submitted QC: 2014-03-17
• Study First Posted: 2014-03-18
• Primary Completion: 2014-09
• Study Completion: 2014-10
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-20
• Last Update Posted: 2017-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 647

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.

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Phenprocoumon (Marcumar)	300 AF patients, with at least 3 month of anticoagulation therapy with VKAs (VKA-experienced patients)
Group 2	Rivaroxaban (Xarelto, BAY-59 7939)	300 AF patients, with at least 3 month of rivaroxaban therapy (rivaroxaban-experienced patients)

Primary Outcome Measures

Name	Time	Method
A prescription of patient preferences pattern including 5 attributes for Discrete-Choice-Experiment(DCE)-design in patients with atrial fibrillation	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
Patient relevant burden/benefit due to anticoagulation using the ACTS-questionnaire	At study entry