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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Bayer
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01805531
First received: March 5, 2013
Last updated: July 30, 2014
Last verified: July 2014

March 5, 2013
July 30, 2014
April 2013
September 2014   (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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01805531 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
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.
Rivaroxaban
Intervention: Drug: Rivaroxaban (Xarelto, BAY59-7939)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
550
March 2015
September 2014   (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
Both
18 Years and older
No
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com
France
 
NCT01805531
16398, XA1213FR
No
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP