Xarelto for Prevention of Stroke in Patients With Atrial Fibrillation (XANTUS)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01606995
First received: May 24, 2012
Last updated: April 14, 2014
Last verified: April 2014
  Purpose

This is an international observational study in patients with non-valvular atrial fibrillation who are prescribed rivaroxaban under routine treatment conditions to prevent stroke or non-central nervous system systemic embolism.


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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Xarelto® on Prevention of Stroke and Non-central Nervous System Systemic Embolism in Patients With Non-valvular Atrial Fibrillation

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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • All cause mortality [ Time Frame: after 1 year or until 30 days after end of rivaroxaban therapy ] [ Designated as safety issue: Yes ]
  • Adjudicated symptomatic thromboembolic events [ Time Frame: after 1 year or until 30 days after end of rivaroxaban therapy ] [ Designated as safety issue: Yes ]
  • Persistence with rivaroxaban treatment: Reasons for any switch from or interruption of rivaroxaban treatment [ Time Frame: after 1 year or until 30 days after end of rivaroxaban therapy ] [ Designated as safety issue: No ]

Estimated Enrollment: 6000
Study Start Date: June 2012
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: December 2014 (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
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with a diagnosis of non-valvular atrial fibrillation who start treatment with rivaroxaban to prevent stroke or non-CNS 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 (Central Nervous System) systemic embolism, and who consent to participate in the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01606995

  Show 21 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01606995     History of Changes
Other Study ID Numbers: 15914, XA1101
Study First Received: May 24, 2012
Last Updated: April 14, 2014
Health Authority: Austria: Federal Office for Safety in Health Care
Belgium: Ethics Committee
Czech Republic: Ethics Committee
Czech Republic: State Institute for Drug Control
Denmark: Danish Dataprotection Agency
Denmark: Danish Medicines Agency
Denmark: Ethics Committee
France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
France: Conseil Natioanl de l´ordre des Médecins
France: Commission nationale de i´informatique et des libertés
Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices
Greece: Ethics Committee
Greece: Ministry of Health and Welfare
Greece: National Organization of Medicines
Hungary: Scientific and Medical Research Council Ethics Committee (ETT-TUKEB)
Ireland: Research Ethics Committee
Israel: Ethics Commission
Israel: Israeli Health Ministry Pharmaceutical Administration
Italy: Ethics Committee
Italy: Registro Study Osservazionali (RSO; National Monitoring Centre for Observational Trials)
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Moldova: Ministry of Health
Moldova: Ethics Committee
Moldova: Medicines Agency
Norway: Norwegian Medicines Agency
Norway: Norwegian Social Science Data Services
Norway: Regional Ethics Committee
Poland: Ethics Committee
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Poland: Head of each study site
Poland: Employers' Union of Innovative Pharmaceutical Companies (INFARMA)
Portugal: National Data Protection Committee (CNPD)
Portugal: Local Ethics Committee
Portugal: National Pharmacy and Medicines Institute (INFARMED)
Russia: Ethics Committee
Russia: Ministry of Health of the Russian Federation
Slovakia: Ethics Committee
Slovakia: State Institute for Drug Control
Slovenia: Ministry of Health
Slovenia: Agency of RS for Mediciinal Products and Medical Devices
Slovenia: National Committee for Medical Ethics
Spain: Ethics Committee
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
Sweden: Regional Ethical Review Board
United Kingdom: Medicines and Healthcare Products Regulatory Agency (only for information, no approval required)
United Kingdom: Research Ethics Committee
Ukraine: Ministry of Health
Ukraine: Ethics Committee
Ukraine: The State Expert Center, Ministry of Health Ukraine
Canada: Ethics Review Committee

Keywords provided by Bayer:
Stroke
Embolism
Atrial fibrillation

Additional relevant MeSH terms:
Atrial Fibrillation
Stroke
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014