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

This study has been completed.
Sponsor:
Collaborator:
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01750788
First received: December 13, 2012
Last updated: September 20, 2017
Last verified: September 2017
December 13, 2012
September 20, 2017
January 13, 2013
October 12, 2015   (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 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 ]
  • 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 NCT01750788 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 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 ]
  • 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 Asia
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
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
Patients with a diagnosis of non-valvular atrial fibrillation who start treatment with rivaroxaban to prevent stroke or non-CNS 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
2297
October 12, 2015
October 12, 2015   (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 (Central Nervous System) systemic embolism, and who consent to participate in the study.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Hong Kong,   India,   Indonesia,   Korea, Republic of,   Malaysia,   Pakistan,   Philippines,   Singapore,   Taiwan,   Thailand,   Vietnam
 
 
NCT01750788
16371
XA1205 ( Other Identifier: Company internal )
No
Not Provided
Not Provided
Bayer
Bayer
Janssen Research & Development, LLC
Study Director: Bayer Study Director Bayer
Bayer
September 2017

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