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

Tracking Information
First Submitted Date	December 13, 2012
First Posted Date	December 17, 2012
Last Update Posted Date	September 21, 2017
Actual Study Start Date	January 13, 2013
Actual Primary Completion Date	October 12, 2015 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures; (submitted: September 20, 2017)	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 ]; All cause mortality [ Time Frame: after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later ]
Original Primary Outcome Measures; (submitted: December 13, 2012)	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 ]
Change History	Complete list of historical versions of study NCT01750788 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures; (submitted: September 20, 2017)	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 as per patient assessment of rivaroxaban treatment by the physician at the final visit [ 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; 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 measured as percentage of patients on rivaroxaban treatment at 1 year after start of study treatment [ Time Frame: after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later ]; Reasons for switch of rivaroxaban treatment as per physician assessment during or at end of study [ Time Frame: after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later ]; Reasons for interruption of rivaroxaban treatment as per physician assessment during or at end of study [ Time Frame: after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later ]
Original Secondary Outcome Measures; (submitted: December 13, 2012)	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 ]
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	Xarelto for Prevention of Stroke in Patients With Atrial Fibrillation in Asia
Official Title	Xarelto® on Prevention of Stroke and Non-central Nervous System Systemic Embolism in Patients With Non-valvular Atrial Fibrillation in Asia: A Non-interventional Study
Brief Summary	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.
Detailed Description	Not Provided
Study Type	Observational
Study Design	Observational Model: Cohort; Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
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
Condition	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.
Study Groups/Cohorts	Group 1; Intervention: Drug: Rivaroxaban (Xarelto, BAY59-7939)
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Completed
Actual Enrollment; (submitted: May 20, 2016)	2297
Original Estimated Enrollment; (submitted: December 13, 2012)	5500
Actual Study Completion Date	October 12, 2015
Actual Primary Completion Date	October 12, 2015 (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	Hong Kong, India, Indonesia, Korea, Republic of, Malaysia, Pakistan, Philippines, Singapore, Taiwan, Thailand, Vietnam
Removed Location Countries
Administrative Information
NCT Number	NCT01750788
Other Study ID Numbers	16371; XA1205 ( Other Identifier: Company internal )
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Bayer
Study Sponsor	Bayer
Collaborators	Janssen Research & Development, LLC
Investigators	Study Director: Bayer Study Director Bayer
PRS Account	Bayer
Verification Date	September 2017