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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01805531
Recruitment Status : Completed
First Posted : March 6, 2013
Last Update Posted : January 18, 2017
Janssen Scientific Affairs, LLC
Information provided by (Responsible Party):

March 5, 2013
March 6, 2013
January 18, 2017
April 2013
January 2015   (Final data collection date for primary outcome measure)
Change of the Anti Clot Treatment Scale (ACTS) score at 3 months compared with baseline score [ Time Frame: After 3 months ]
Same as current
Complete list of historical versions of study NCT01805531 on Archive Site
  • Change of ACTS score after 1 and 6 months of treatment [ Time Frame: After 1 and 6 months ]
  • Continuation rate at 1, 3 and 6 months [ Time Frame: After 1, 3 and 6 months ]
  • 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 ]
  • 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 ]
  • 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 ]
Same as current
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Satisfaction/Quality of Life With Rivaroxaban in SPAF (Stroke Prevention in Atrial Fibrillation) Indication
Satisfaction and Quality of Life in Patients With a Diagnosis of Non Valvular Atrial Fibrillation Who Take Rivaroxaban for Stroke Prevention
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.
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Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
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
Atrial Fibrillation
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.
Intervention: Drug: Rivaroxaban (Xarelto, BAY59-7939)
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
March 2015
January 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
XA1213FR ( Other Identifier: Company internal )
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Janssen Scientific Affairs, LLC
Study Director: Bayer Study Director Bayer
January 2017