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

NCT ID: NCT02090543

Last Updated: 2017-01-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 647 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2014-10-31

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.

Conditions

Atrial Fibrillation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Group 1

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

Phenprocoumon (Marcumar)

Intervention Type: DRUG

common use, no requirements (real life situation)

Group 2

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

Rivaroxaban (Xarelto, BAY-59 7939)

Intervention Type: DRUG

common use, no requirements (real life situation)

Interventions

Phenprocoumon (Marcumar)

common use, no requirements (real life situation)

Intervention Type: DRUG

Rivaroxaban (Xarelto, BAY-59 7939)

common use, no requirements (real life situation)

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: collaborator

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Many Locations, , Germany

Countries

Germany

Other Identifiers

OR-ITW-01-13

Identifier Type: OTHER

Identifier Source: secondary_id

17019

Identifier Type: -

Identifier Source: org_study_id