Trial Condition(s):

Atrial Fibrillation

Satisfaction/Quality of Life with Rivaroxaban in SPAF (stroke prevention in atrial fibrillation) indication (SAFARI)

Bayer Identifier:

16398

ClinicalTrials.gov Identifier:

NCT01805531

EudraCT Number:

Not Available

Study Completed

Trial 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.

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

Trial Summary

Enrollment Goal
411
Trial Dates
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Phase
N/A
Could I receive a placebo?
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Many locations, France

Status
Completed
 

Trial Design