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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01750788
First Posted: December 17, 2012
Last Update Posted: September 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Bayer
  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 in Asia: 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 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 ]

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 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 ]

Enrollment: 2297
Actual Study Start Date: January 13, 2013
Study Completion Date: October 12, 2015
Primary Completion Date: October 12, 2015 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01750788


Locations
Hong Kong
Many Locations, Hong Kong
India
Many Locations, India
Indonesia
Many Locations, Indonesia
Korea, Republic of
Many Locations, Korea, Republic of
Malaysia
Many Locations, Malaysia
Pakistan
Many Locations, Pakistan
Philippines
Many Locations, Philippines
Singapore
Many Locations, Singapore
Taiwan
Many Locations, Taiwan
Thailand
Many Locations, Thailand
Vietnam
Many Locations, Vietnam
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: NCT01750788     History of Changes
Other Study ID Numbers: 16371
XA1205 ( Other Identifier: Company internal )
First Submitted: December 13, 2012
First Posted: December 17, 2012
Last Update Posted: September 21, 2017
Last Verified: September 2017

Keywords provided by Bayer:
Stroke
Embolism
Atrial Fibrillation

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


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