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

N/ACompletedNCT02090543

Bayer647 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

647

Conditions

Atrial Fibrillation

Interventions

Phenprocoumon (Marcumar)DRUG

common use, no requirements (real life situation)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: Within 1-4 weeks after patient enrollement

Patient relevant burden/benefit due to anticoagulation using the ACTS-questionnaire

Time frame: At study entry