Satisfaction/Quality of Life With Rivaroxaban in SPAF (Stroke Prevention in Atrial Fibrillation) Indication

• Status: Completed
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: All

Summary

National, multicenter, prospective, observational, non-interventional study. The objective is to determine if the switch from Vitamin K antagonists (VKA) to Xarelto in subjects treated with VKA with issues for stroke prevention in non valvular atrial fibrillation is associated with an improvement of the treatment satisfaction after 3 months. The treatment satisfaction will be measured by the Anti Clot Treatment Scale (ACTS) score.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Collaborator: Janssen Scientific Affairs, LLC
• Treatments: Rivaroxaban

Criteria

Inclusion Criteria:

• Female and male subjects ≥ 18 years of age with a diagnosis of non-valvular atrial fibrillation

• Who are treated with Vitamin K antagonists (VKA) with issues for at least the 4 previous weeks (issues are assessed on medical judgment)

• Who start treatment with rivaroxaban to prevent stroke or non-CNS (central nervous system) systemic embolism

• With anticoagulation therapy planned for at least 6 months

Exclusion Criteria:

• Contra indication to the use of Xarelto as described in the Summary of Product Characteristics (SmPC); key contra indications are:

• Hypersensitivity to the active substance or to any of the excipients listed in SmPC section 6.1.

• Lesion or condition at significant risk of major bleeding

• Concomitant treatment with any other anticoagulant agent

• Clinically significant active bleeding

• Hepatic disease associated with coagulopathy and clinically relevant bleeding risk including cirrhotic patients with Child Pugh B and C

• Pregnancy and breast feeding