Completed

NCT Number: NCT01800006

Xarelto for Prevention of Stroke in Patients With Atrial Fibrillation in Latinamerica and EMEA Region

This international study is a prospective noninterventional observational cohort study of patients with non-valvular atrial fibrillation who are prescribed rivaroxaban under routine treatment conditions to prevent stroke or non-central nervous system systemic embolism. Patients will be followed up for 1 year or until 30 days after end of rivaroxaban therapy in case of therapy was discontinued earlier than 12 months. Serious adverse events will be followed up adequately. Laboratory values (e.g., Hb, HCT, haemoccult) should be documented for each point in time they were measured.

Completed

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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, Argentina

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 systemic embolism, and who consent to participate in the study.

Exclusion criteria

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 descriptivestatistics 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

Time frame: 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

Time frame: after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
Persistence with rivaroxaban treatment

Time frame: after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
Reasons for switch of rivaroxaban treatment

Time frame: after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
Reasons for interruption of rivaroxaban treatment

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 therapy

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

Janssen Research & Development, LLC

Registry information

Official study title

XANTUS-EL, Xarelto® on Prevention of Stroke and Noncentral Nervous System Systemic Embolism in Patients With Non-valvular Atrial Fibrillation in Eastern EU, Middle East, Africa (EMEA) and Latin America (LATAM): A Non-interventional Study

Acronym: XANTUS-EL

Important dates

Study start: 2013
Primary completion: 2016
Study completion: 2016
First posted: Feb 27, 2013
Registry last updated: Jun 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