An observational study in Atrial Fibrillation, sponsored by Bayer. Completed at 17 sites in 17 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-06-21.
Sponsored by Bayer · Observational
This international study is a prospective noninterventional observational cohort study of patients with non-valvular atrial fibrillation who are prescribed rivaroxaban under routine treatment conditions to prevent stroke or non-central nervous system systemic embolism. Patients will be followed up for 1 year or until 30 days after end of rivaroxaban therapy in case of therapy was discontinued earlier than 12 months. Serious adverse events will be followed up adequately. Laboratory values (e.g., Hb, HCT, haemoccult) should be documented for each point in time they were measured.
4,009 studies on the registry are indexed under Atrial Fibrillation; 961 are open to participants now.
This study's enrollment of 2,101 is above the median of 300 across 1,400 observational studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Bayer is the lead sponsor of 1,674 studies on the registry; 51 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 132 (62%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients with non-valvular atrial fibrillation who are prescribed rivaroxaban under routine treatment conditions to prevent stroke or noncentral nervous system systemic embolism.
Exclusion Criteria:
Drug: Rivaroxaban (Xarelto, BAY59-7939)
Patients with non-valvular atrial fibrillation who are prescribed Rivaroxaban under routine treatment conditions to prevent stroke or non-central nervous system systemic embolism. Decision regarding dose and duration of treatment made at the discretion of the attending investigator.
Adjudicated major bleeding events
Time frame: after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
Safety variables will be summarized using descriptivestatistics based on adverse events collection
Time frame: after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
All cause mortality
Time frame: after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
Adjudicated symptomatic thromboembolic events
Time frame: after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
Non-major bleeding, collected as SAEs or non-serious AEs and defined as all bleeding events that do not fall in the category of major bleedings
Time frame: after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
Treatment satisfaction
Time frame: after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
Adverse events rates in the different AF risk factor categories
Time frame: after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
Persistence with rivaroxaban treatment
Time frame: after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
Reasons for switch of rivaroxaban treatment
Time frame: after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
Reasons for interruption of rivaroxaban treatment
Time frame: after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
Healthcare resource
Number of healthcare professional visits and hospitalizations due to anticoagulation therapy
Time frame: after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.
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