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Completed

NCT Number: NCT01606995

Xarelto for Prevention of Stroke in Patients With Atrial Fibrillation

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

Multiple Locations, Austria

Loading trial locations.

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

  1. Adjudicated major bleeding events

    Time frame: after 1 year or until 30 days after end of rivaroxaban therapy

  2. 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

Secondary outcomes

  1. All cause mortality

    Time frame: after 1 year or until 30 days after end of rivaroxaban therapy

  2. Adjudicated symptomatic thromboembolic events

    Time frame: after 1 year or until 30 days after end of rivaroxaban therapy

  3. Persistence with rivaroxaban treatment: Reasons for any switch from or interruption of rivaroxaban treatment

    Time frame: after 1 year or until 30 days after end of rivaroxaban therapy

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

Acronym: XANTUS

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
May 28, 2012
Registry last updated
Aug 3, 2022

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.

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