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

This study is currently recruiting participants.
Verified April 2014 by Bayer
Information provided by (Responsible Party):
Bayer Identifier:
First received: March 5, 2013
Last updated: April 2, 2014
Last verified: April 2014

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.

Condition Intervention
Atrial Fibrillation
Drug: Rivaroxaban (Xarelto, BAY59-7939)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Satisfaction and Quality of Life in Patients With a Diagnosis of Non Valvular Atrial Fibrillation Who Take Rivaroxaban for Stroke Prevention

Resource links provided by NLM:

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Change of the Anti Clot Treatment Scale (ACTS) score at 3 months compared with baseline score [ Time Frame: After 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change of ACTS score after 1 and 6 months of treatment [ Time Frame: After 1 and 6 months ] [ Designated as safety issue: No ]
  • Continuation rate at 1, 3 and 6 months [ Time Frame: After 1, 3 and 6 months ] [ Designated as safety issue: No ]
  • Change of SF36 score at 1, 3 and 6 months (health related quality of life determined by SF36 questionnaire) [ Time Frame: After 1, 3 and 6 months ] [ Designated as safety issue: No ]
  • 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") [ Time Frame: After 1, 3 and 6 months ] [ Designated as safety issue: No ]
  • 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%) [ Time Frame: After 1, 3 and 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 550
Study Start Date: April 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Rivaroxaban Drug: Rivaroxaban (Xarelto, BAY59-7939)
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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study 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


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
  Contacts and Locations
Please refer to this study by its identifier: NCT01805531

Contact: Bayer Clinical Trials Contact

Many locations, France
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer Identifier: NCT01805531     History of Changes
Other Study ID Numbers: 16398, XA1213FR
Study First Received: March 5, 2013
Last Updated: April 2, 2014
Health Authority: France: none

Keywords provided by Bayer:
SF36 questionnaire
Anti Clot Treatment Scale
Quality of Life
Stroke prevention

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases processed this record on April 17, 2014