Xarelto for Prevention of Stroke in Patients With Atrial Fibrillation in Asia

Atrial Fibrillation Clinical Trial

— XANAP  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01750788
• Other study ID #: 16371
• Secondary ID: XA1205
• Status: Completed
• Phase: N/A
• First received: December 13, 2012
• Last updated: September 20, 2017
• Start date: January 13, 2013
• Est. completion date: October 12, 2015

Study information

• Verified date: September 2017
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2297
• Est. completion date: October 12, 2015
• Est. primary completion date: October 12, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Janssen Research & Development, LLC

Countries where clinical trial is conducted

Hong Kong,  India,  Indonesia,  Korea, Republic of,  Malaysia,  Pakistan,  Philippines,  Singapore,  Taiwan,  Thailand,  Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adjudicated major bleeding events		after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
Primary	Safety variables will be summarized using descriptive statistics based on adverse events collection		after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
Primary	All cause mortality		after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
Secondary	Adjudicated symptomatic thromboembolic events		after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
Secondary	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		after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
Secondary	Treatment satisfaction as per patient assessment of rivaroxaban treatment by the physician at the final visit		after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
Secondary	Healthcare resource	Number of healthcare professional visits and hospitalizations due to anticoagulation	after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
Secondary	Adverse events rates in the different AF risk factor categories		after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
Secondary	Persistence with rivaroxaban treatment measured as percentage of patients on rivaroxaban treatment at 1 year after start of study treatment		after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
Secondary	Reasons for switch of rivaroxaban treatment as per physician assessment during or at end of study		after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
Secondary	Reasons for interruption of rivaroxaban treatment as per physician assessment during or at end of study		after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later

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