Overview

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