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

Atrial Fibrillation Clinical Trial

— XANTUS-EL  

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 Non-interventional Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01800006
• Other study ID #: 16691
• Secondary ID: XA1206
• Status: Completed
• Phase: N/A
• First received: February 25, 2013
• Last updated: June 20, 2017
• Start date: January 14, 2013
• Est. completion date: June 20, 2016

Study information

• Verified date: June 2017
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2101
• Est. completion date: June 20, 2016
• Est. primary completion date: January 16, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Janssen Research & Development, LLC

Countries where clinical trial is conducted

Argentina,  Azerbaijan,  Bahrain,  Chile,  Colombia,  Egypt,  Georgia,  Jordan,  Kazakhstan,  Kenya,  Lebanon,  Mexico,  Russian Federation,  Saudi Arabia,  United Arab Emirates,  Uruguay,  Venezuela, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adjudicated major bleeding events		after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
Primary	Safety variables will be summarized using descriptivestatistics based on adverse events collection		after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
Primary	All cause mortality		after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
Secondary	Adjudicated symptomatic thromboembolic events		after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
Secondary	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		after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
Secondary	Treatment satisfaction		after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
Secondary	Adverse events rates in the different AF risk factor categories		after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
Secondary	Persistence with rivaroxaban treatment		after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
Secondary	Reasons for switch of rivaroxaban treatment		after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
Secondary	Reasons for interruption of rivaroxaban treatment		after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
Secondary	Healthcare resource	Number of healthcare professional visits and hospitalizations due to anticoagulation therapy	after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later

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