Satisfaction and Quality of Life in Patients With a Diagnosis of Non Valvular Atrial Fibrillation Who Take Rivaroxaban for Stroke Prevention

Bayer0 sites411 target enrollmentApril 2013

ConditionsAtrial Fibrillation

InterventionsRivaroxaban (Xarelto, BAY59-7939)

DrugsRivaroxaban (Xarelto, BAY59-7939)

Overview

Phase: Not Applicable
Intervention: Rivaroxaban (Xarelto, BAY59-7939)
Conditions: Atrial Fibrillation
Sponsor: Bayer
Enrollment: 411
Primary Endpoint: Change of the Anti Clot Treatment Scale (ACTS) score at 3 months compared with baseline score
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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 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.

Registry

clinicaltrials.gov

Start Date

April 2013

End Date

March 2015

Last Updated

9 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Bayer

Responsible Party

Sponsor

Eligibility 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.
•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

Arms & Interventions

Rivaroxaban

Intervention: Rivaroxaban (Xarelto, BAY59-7939)

Outcomes

Primary Outcomes

Change of the Anti Clot Treatment Scale (ACTS) score at 3 months compared with baseline score

Time Frame: After 3 months

Secondary Outcomes

Continuation rate at 1, 3 and 6 months(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%)(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")(After 1, 3 and 6 months)
Change of ACTS score after 1 and 6 months of treatment(After 1 and 6 months)
Change of SF36 score at 1, 3 and 6 months (health related quality of life determined by SF36 questionnaire)(After 1, 3 and 6 months)