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

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Phenprocoumon (Marcumar)

Drug

common use, no requirements (real life situation)

Rivaroxaban (Xarelto, BAY-59 7939)

Drug

common use, no requirements (real life situation)

Primary outcomes

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

Time frame: At study entry

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

Janssen Research & Development, LLC

Registry information

Official study title

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

Important dates

Study start: 2014
Primary completion: 2014
Study completion: 2014
First posted: Mar 18, 2014
Registry last updated: Jan 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed