Status:
COMPLETED
Satisfaction/Quality of Life With Rivaroxaban in SPAF (Stroke Prevention in Atrial Fibrillation) Indication
Lead Sponsor:
Bayer
Collaborating Sponsors:
Janssen Scientific Affairs, LLC
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Brief Summary
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 i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
411 Patients enrolled
Trial Details
Trial ID
NCT01805531
Start Date
April 1 2013
End Date
March 1 2015
Last Update
January 18 2017
Active Locations (1)
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1
Many Locations, France