SAFARISatisfaction and Quality of Life in Patients With a Diagnosis of Non Valvular Atrial Fibrillation Who Take Rivaroxaban for Stroke Prevention
Drug Data
Collected from today forward - ProspectiveArrhythmias, Cardiac+5
+ Behavior
+ Cardiovascular Diseases
Cohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
Study start date: April 1, 2013
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.411 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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 6.1. 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
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location