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

Bayer

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Drug: Rivaroxaban (Xarelto, BAY59-7939)

Study type: Observational

Funder types: Industry

Identifiers

NCT01805531

XA1213FR (Other Identifier)

16398

Details and patient eligibility

About

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.

Enrollment: 411 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

411 participants in 1 patient group

Rivaroxaban

Treatment:

Drug: Rivaroxaban (Xarelto, BAY59-7939)