Completed

NCT Number: NCT01750788

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

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Embolism Embolism and Thrombosis Heart Diseases Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations, Hong Kong

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rivaroxaban (Xarelto, BAY59-7939)

Drug

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.

Primary outcomes

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 outcomes

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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

Janssen Research & Development, LLC

Registry information

Official study 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

Acronym: XANAP

Important dates

Study start: 2013
Primary completion: 2015
Study completion: 2015
First posted: Dec 17, 2012
Registry last updated: Sep 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed