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

Bayer

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Drug: Phenprocoumon (Marcumar); Drug: Rivaroxaban (Xarelto, BAY-59 7939)

Study type: Observational

Funder types: Industry

Identifiers

NCT02090543

17019

OR-ITW-01-13 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 647 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

647 participants in 2 patient groups

Group 1

Description:

300 AF patients, with at least 3 month of anticoagulation therapy with VKAs (VKA-experienced patients)

Treatment:

Drug: Phenprocoumon (Marcumar)

Group 2

Description:

300 AF patients, with at least 3 month of rivaroxaban therapy (rivaroxaban-experienced patients)

Treatment:

Drug: Rivaroxaban (Xarelto, BAY-59 7939)