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

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Drug: Rivaroxaban (Xarelto, BAY59-7939)

• Study Type: Observational
• Enrollment (Actual): 2297

Contacts and Locations

Study 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Adjudicated major bleeding events	after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
All cause mortality	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	after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adjudicated symptomatic thromboembolic events		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		after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Bayer
• Collaborators: Janssen Research & Development, LLC

Publications and helpful links

General Publications

• Kirchhof P, Radaideh G, Kim YH, Lanas F, Haas S, Amarenco P, Turpie AGG, Bach M, Lambelet M, Hess S, Camm AJ; Global XANTUS program Investigators. Global Prospective Safety Analysis of Rivaroxaban. J Am Coll Cardiol. 2018 Jul 10;72(2):141-153. doi: 10.1016/j.jacc.2018.04.058.

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2013
• Primary Completion (Actual): October 12, 2015
• Study Completion (Actual): October 12, 2015

Study Registration Dates

• First Submitted: December 13, 2012
• First Submitted That Met QC Criteria: December 13, 2012
• First Posted (Estimate): December 17, 2012

Study Record Updates

• Last Update Posted (Actual): September 21, 2017
• Last Update Submitted That Met QC Criteria: September 20, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: Stroke; Atrial Fibrillation; Embolism
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Rivaroxaban
• Other Study ID Numbers: 16371; XA1205 (Other Identifier: Company internal)