Xarelto for Prevention of Stroke in Patients With Atrial Fibrillation in Latinamerica and EMEA Region

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01800006
• Date of registration: 25/02/2013
• Prospective Registration: No
• Primary sponsor: Bayer
• Public title: Xarelto for Prevention of Stroke in Patients With Atrial Fibrillation in Latinamerica and EMEA Region XANTUS-EL
• Scientific 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 Non-interventional Study
• Date of first enrolment: January 14, 2013
• Target sample size: 2101
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01800006
• Study type: Observational
• Phase: N/A

Countries of recruitment

Algeria, Argentina, Azerbaijan, Bahrain, Chile, Colombia, Ecuador, Egypt, Georgia, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Mexico, Morocco, Peru, Qatar, Russian Federation, Saudi Arabia, Ukraine, United Arab Emirates, Uruguay, Venezuela

Contacts

• Name: Bayer Study Director
• Affiliation: Bayer

Key inclusion & exclusion 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:



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Atrial Fibrillation

Intervention(s)

Drug: Rivaroxaban (Xarelto, BAY59-7939)

Primary Outcome(s)

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]

Secondary Outcome(s)

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]

Reasons for switch of rivaroxaban treatment [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 interruption of rivaroxaban treatment [Time Frame: after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later]

Healthcare resource [Time Frame: after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later]

Secondary ID(s)

XA1206

16691

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Janssen Research & Development, LLC