Xarelto for Prevention of Stroke in Patients With Atrial Fibrillation - Full Text View

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:

Genetics Home Reference related topics: familial atrial fibrillation

MedlinePlus related topics: Atrial Fibrillation

Drug Information available for: Rivaroxaban

U.S. FDA Resources

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

Contacts

Contact: Bayer Clinical Trials Contact

clinical-trials-contact@bayerhealthcare.com

Hide Study Locations

Locations

Austria
	Recruiting
Many Locations, Austria
Belgium
	Recruiting
Many Locations, Belgium
Canada
	Recruiting
Many Locations, Canada
Czech Republic
	Recruiting
Many Locations, Czech Republic
Denmark
	Recruiting
Many Locations, Denmark
France
	Recruiting
Many Locations, France
Germany
	Recruiting
Many Locations, Germany
Greece
	Not yet recruiting
Many Locations, Greece
Hungary
	Recruiting
Many Locations, Hungary
Ireland
	Not yet recruiting
Many Locations, Ireland
Israel
	Recruiting
Many Locations, Israel
Italy
	Not yet recruiting
Many Locations, Italy
Moldova, Republic of
	Not yet recruiting
Many Locations, Moldova, Republic of
Netherlands
	Recruiting
Many Locations, Netherlands
Norway
	Recruiting
Many Locations, Norway
Poland
	Recruiting
Many Locations, Poland
Portugal
	Recruiting
Many Locations, Portugal
Russian Federation
	Recruiting
Many Locations, Russian Federation
Slovakia
	Recruiting
Many Locations, Slovakia
Slovenia
	Recruiting
Many Locations, Slovenia
Spain
	Terminated
Many Locations, Spain
Sweden
	Recruiting
Many Locations, Sweden
Ukraine
	Recruiting
Many Locations, Ukraine
United Kingdom
	Recruiting
Many Locations, United Kingdom

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

Click here and search for drug information provided by the FDA. This link exits the ClinicalTrials.gov site

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Global Medical Affairs Therapeutic Area Head, Bayer HealthCare AG
ClinicalTrials.gov Identifier:	NCT01606995 History of Changes
Other Study ID Numbers:	15914, XA1101
Study First Received:	May 24, 2012
Last Updated:	June 11, 2013
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 June 17, 2013

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