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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01805531
First received: March 5, 2013
Last updated: October 26, 2014
Last verified: October 2014
  Purpose

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 ]

Enrollment: 376
Study Start Date: April 2013
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: December 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.

  Eligibility

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

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01805531

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

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01805531     History of Changes
Other Study ID Numbers: 16398, XA1213FR
Study First Received: March 5, 2013
Last Updated: October 26, 2014
Health Authority: France: none

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

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes
Rivaroxaban
Anticoagulants
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014