Xarelto for Prevention of Stroke in Patients With Atrial Fibrillation

Atrial Fibrillation Clinical Trial

— XANTUS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01606995
• Other study ID #: 15914
• Secondary ID: XA1101
• Status: Completed
• Start date: June 12, 2012
• Est. completion date: March 31, 2015

Study information

• Verified date: July 2022
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6784
• Est. completion date: March 31, 2015
• Est. primary completion date: March 6, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Janssen Research & Development, LLC

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adjudicated major bleeding events		after 1 year or until 30 days after end of rivaroxaban therapy
Primary	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
Secondary	All cause mortality		after 1 year or until 30 days after end of rivaroxaban therapy
Secondary	Adjudicated symptomatic thromboembolic events		after 1 year or until 30 days after end of rivaroxaban therapy
Secondary	Persistence with rivaroxaban treatment: Reasons for any switch from or interruption of rivaroxaban treatment		after 1 year or until 30 days after end of rivaroxaban therapy

External Links

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