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

Completed

Phase N/A Results N/A

Trial Description

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.

Conditions

Interventions

  • Rivaroxaban (Xarelto, BAY59-7939) Drug
    Intervention Desc: 20 mg po once daily, which is also the recommended maximum dose. In subjects with moderate creatinine clearance (30-49 ml/min), the dose 15 mg once daily is recommended.
    ARM 1: Kind: Experimental
    Label: Rivaroxaban

Trial Design

  • Observation: Cohort
  • Perspective: Prospective
  • Sampling: Non-Probability Sample

Trial Population

Patients more than 18 years old, with a diagnosis of non-valvular atrial fibrillation, treated to prevent stroke or non-central nervous system systemic embolism, who switch from VKA to Xarelto due to issues with VKA

Outcomes

Type Measure Time Frame Safety Issue
Primary Change of the Anti Clot Treatment Scale (ACTS) score at 3 months compared with baseline score After 3 months No
Secondary Change of ACTS score after 1 and 6 months of treatment After 1 and 6 months No
Secondary Continuation rate at 1, 3 and 6 months After 1, 3 and 6 months No
Secondary Change of SF36 score at 1, 3 and 6 months (health related quality of life determined by SF36 questionnaire) After 1, 3 and 6 months No
Secondary Physician's satisfaction at 1, 3 and 6 months assessed by a 5-point Likert scale response ("very satisfied", "satisfied", "neutral", "unsatisfied" or "very unsatisfied") After 1, 3 and 6 months No
Secondary Patient's compliance with VKA treatment at baseline and with Xarelto treatment at 1, 3 and 6 months assessed by the investigator as good (≥80%), average (50-80%) or poor (<50%) After 1, 3 and 6 months No
Primary Change of the Anti Clot Treatment Scale (ACTS) score at 3 months compared with baseline score After 3 months No

Sponsors