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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
  Purpose
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.

Condition Intervention
Atrial Fibrillation Drug: Rivaroxaban (Xarelto, BAY59-7939)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 Measures:
  • 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


Enrollment: 2101
Actual Study Start Date: January 14, 2013
Study Completion Date: June 20, 2016
Primary Completion Date: January 16, 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with non-valvular atrial fibrillation who are prescribed rivaroxaban under routine treatment conditions to prevent stroke or noncentral nervous system systemic embolism.
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:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01800006

  Hide Study Locations
Locations
Argentina
Many Locations, Argentina
Azerbaijan
Many Locations, Azerbaijan
Bahrain
Many Locations, Bahrain
Chile
Many Locations, Chile
Colombia
Many Locations, Colombia
Egypt
Many Locations, Egypt
Georgia
Many Locations, Georgia
Jordan
ManyLocations, Jordan
Kazakhstan
Many Locations, Kazakhstan
Kenya
Many Locations, Kenya
Lebanon
ManyLocations, Lebanon
Mexico
Many Locations, Mexico
Russian Federation
Many Locations, Russian Federation
Saudi Arabia
ManyLocations, Saudi Arabia
United Arab Emirates
Many Locations, United Arab Emirates
Uruguay
Many Locations, Uruguay
Venezuela
Many Locations, Venezuela
Sponsors and Collaborators
Bayer
Janssen Research & Development, LLC
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01800006     History of Changes
Other Study ID Numbers: 16691
XA1206 ( Other Identifier: Company internal )
Study First Received: February 25, 2013
Last Updated: June 20, 2017

Keywords provided by Bayer:
Atrial Fibrillation
Observation
Stroke
Embolism

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Rivaroxaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants

ClinicalTrials.gov processed this record on September 21, 2017