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Xarelto for Prevention of Stroke in Patients With Atrial Fibrillation in Latinamerica and EMEA Region (XANTUS-EL)

This study has been completed.
Sponsor:
Collaborator:
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01800006
First received: February 25, 2013
Last updated: June 20, 2017
Last verified: June 2017
February 25, 2013
June 20, 2017
January 14, 2013
January 16, 2016   (Final data collection date for primary outcome measure)
  • 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 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 descriptive statistics based on adverse events collection [ Time Frame: after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later ]
Complete list of historical versions of study NCT01800006 on ClinicalTrials.gov Archive Site
  • 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 [ Time Frame: after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later ]
    Number of healthcare professional visits and hospitalizations due to anticoagulation therapy
  • 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 ]
Not Provided
Not Provided
 
Xarelto for Prevention of Stroke in Patients With Atrial Fibrillation in Latinamerica and EMEA Region
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
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
Patients with non-valvular atrial fibrillation who are prescribed rivaroxaban under routine treatment conditions to prevent stroke or noncentral nervous system systemic embolism.
Atrial Fibrillation
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.
Group 1
Intervention: Drug: Rivaroxaban (Xarelto, BAY59-7939)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2101
June 20, 2016
January 16, 2016   (Final data collection date for primary outcome measure)

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:

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Azerbaijan,   Bahrain,   Chile,   Colombia,   Egypt,   Georgia,   Jordan,   Kazakhstan,   Kenya,   Lebanon,   Mexico,   Russian Federation,   Saudi Arabia,   United Arab Emirates,   Uruguay,   Venezuela
Algeria,   Ecuador,   Kuwait,   Morocco,   Peru,   Qatar,   Ukraine
 
NCT01800006
16691
XA1206 ( Other Identifier: Company internal )
No
Not Provided
Not Provided
Bayer
Bayer
Janssen Research & Development, LLC
Study Director: Bayer Study Director Bayer
Bayer
June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP