- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01805531
Satisfaction/Quality of Life With Rivaroxaban in SPAF (Stroke Prevention in Atrial Fibrillation) Indication (SAFARI)
January 17, 2017 updated by: Bayer
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
411
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Many locations, France
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Rivaroxaban
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change of the Anti Clot Treatment Scale (ACTS) score at 3 months compared with baseline score
Time Frame: After 3 months
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After 3 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change of ACTS score after 1 and 6 months of treatment
Time Frame: After 1 and 6 months
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After 1 and 6 months
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Continuation rate at 1, 3 and 6 months
Time Frame: After 1, 3 and 6 months
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After 1, 3 and 6 months
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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
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After 1, 3 and 6 months
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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
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After 1, 3 and 6 months
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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
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After 1, 3 and 6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2013
Primary Completion (Actual)
January 1, 2015
Study Completion (Actual)
March 1, 2015
Study Registration Dates
First Submitted
March 5, 2013
First Submitted That Met QC Criteria
March 5, 2013
First Posted (Estimate)
March 6, 2013
Study Record Updates
Last Update Posted (Estimate)
January 18, 2017
Last Update Submitted That Met QC Criteria
January 17, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16398
- XA1213FR (Other Identifier: Company internal)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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