Xarelto for Prevention of Stroke in Patients With Atrial Fibrillation in Latinamerica and EMEA Region
Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Atrial Fibrillation
Intervention: Rivaroxaban (Xarelto, BAY59-7939) (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Bayer Official(s) and/or principal investigator(s): Bayer Study Director, Study Director, Affiliation: Bayer
Overall contact: Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com
Summary
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.
Clinical Details
Official title: XANTUS-EL, Xarelto® on Prevention of Stroke and Noncentral Nervous System Systemic Embolism in Patients With Non-valvular Atrial Fibrillation in Eastern EU, Middle East, Africa (EMEA) and Latin America (LATAM): A Noninterventional Study
Study design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: Adjudicated major bleeding eventsSafety variables will be summarized using descriptivestatistics based on adverse events collection
Secondary outcome: All cause mortalityAdjudicated symptomatic thromboembolic events
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Female and male patients ≥ 18 years of age with a diagnosis of non-valvular atrial
fibrillation who start treatment with rivaroxaban to prevent stroke or non-CNS
systemic embolism, and who consent to participate in the study.
Exclusion Criteria:
-
Locations and Contacts
Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com
Many Locations, Algeria; Not yet recruiting
Many Locations, Argentina; Recruiting
Many Locations, Azerbaijan; Recruiting
Many Locations, Bahrain; Recruiting
Many Locations, Chile; Recruiting
Many Locations, Colombia; Recruiting
Many Locations, Ecuador; Not yet recruiting
Many Locations, Egypt; Recruiting
Many Locations, Georgia; Recruiting
ManyLocations, Jordan; Recruiting
Many Locations, Kazakhstan; Recruiting
Many Locations, Kazakhstan; Not yet recruiting
Many Locations, Kenya; Recruiting
Many Locations, Kuwait; Not yet recruiting
ManyLocations, Lebanon; Recruiting
Many Locations, Mexico; Recruiting
Many Locations, Morocco; Withdrawn
Many Locations, Peru; Not yet recruiting
Many Locations, Qatar; Not yet recruiting
Many Locations, Russian Federation; Recruiting
ManyLocations, Saudi Arabia; Recruiting
Many Locations, Ukraine; Withdrawn
Many Locations, United Arab Emirates; Recruiting
Many Locations, Uruguay; Recruiting
Many Locations, Venezuela; Recruiting
Additional Information
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Starting date: January 2013
Last updated: June 25, 2015
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