An observational study in Atrial Fibrillation, sponsored by Bayer. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-01-18.
Sponsored by Bayer · Observational
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.
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's enrollment of 411 is above the median of 300 across 1,363 observational studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.
Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.
Counted across the registry records on this site, refreshed daily.
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
Exclusion Criteria:
Contra indication to the use of Xarelto as described in the Summary of Product Characteristics (SmPC); key contra indications are:
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.
Change of the Anti Clot Treatment Scale (ACTS) score at 3 months compared with baseline score
Time frame: After 3 months
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
This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.
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