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Xarelto for Prevention of Stroke in Patients With Atrial Fibrillation

Xarelto® on Prevention of Stroke and Non-central Nervous System Systemic Embolism in Patients With Non-valvular Atrial Fibrillation

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01606995
Acronym
XANTUS
Enrollment
6784
Registered
2012-05-28
Start date
2012-06-12
Completion date
2015-03-31
Last updated
2022-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Keywords

Stroke, Embolism, Atrial fibrillation

Brief 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.

Interventions

DRUGRivaroxaban (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

Sponsors

Janssen Research & Development, LLC
CollaboratorINDUSTRY
Bayer
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Adjudicated major bleeding eventsafter 1 year or until 30 days after end of rivaroxaban therapy
Safety variables will be summarized using descriptive statistics based on adverse events collectionafter 1 year or until 30 days after end of rivaroxaban therapy

Secondary

MeasureTime frame
All cause mortalityafter 1 year or until 30 days after end of rivaroxaban therapy
Adjudicated symptomatic thromboembolic eventsafter 1 year or until 30 days after end of rivaroxaban therapy
Persistence with rivaroxaban treatment: Reasons for any switch from or interruption of rivaroxaban treatmentafter 1 year or until 30 days after end of rivaroxaban therapy

Countries

Austria, Belgium, Canada, Czechia, Denmark, France, Germany, Hungary, Ireland, Israel, Moldova, Netherlands, Norway, Poland, Portugal, Russia, Slovakia, Slovenia, Sweden, Ukraine, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026