Xarelto for Prevention of Stroke in Patients With Atrial Fibrillation (XANTUS)
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ClinicalTrials.gov Identifier: NCT01606995 |
Recruitment Status :
Completed
First Posted : May 28, 2012
Last Update Posted : August 3, 2022
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Condition or disease | Intervention/treatment |
---|---|
Atrial Fibrillation | Drug: Rivaroxaban (Xarelto, BAY59-7939) |
Study Type : | Observational |
Actual Enrollment : | 6784 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Xarelto® on Prevention of Stroke and Non-central Nervous System Systemic Embolism in Patients With Non-valvular Atrial Fibrillation |
Actual Study Start Date : | June 12, 2012 |
Actual Primary Completion Date : | March 6, 2015 |
Actual Study Completion Date : | March 31, 2015 |

Group/Cohort | Intervention/treatment |
---|---|
Group 1 |
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 |
- Adjudicated major bleeding events [ Time Frame: after 1 year or until 30 days after end of rivaroxaban therapy ]
- 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 ]
- All cause mortality [ Time Frame: after 1 year or until 30 days after end of rivaroxaban therapy ]
- Adjudicated symptomatic thromboembolic events [ Time Frame: after 1 year or until 30 days after end of rivaroxaban therapy ]
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01606995
Austria | |
Multiple Locations, Austria | |
Belgium | |
Multiple Locations, Belgium | |
Canada | |
Multiple Locations, Canada | |
Czechia | |
Multiple Locations, Czechia | |
Denmark | |
Multiple Locations, Denmark | |
France | |
Multiple Locations, France | |
Germany | |
Multiple Locations, Germany | |
Hungary | |
Multiple Locations, Hungary | |
Ireland | |
Multiple Locations, Ireland | |
Israel | |
Multiple Locations, Israel | |
Moldova, Republic of | |
Multiple Locations, Moldova, Republic of | |
Netherlands | |
Multiple Locations, Netherlands | |
Norway | |
Multiple Locations, Norway | |
Poland | |
Multiple Locations, Poland | |
Portugal | |
Multiple Locations, Portugal | |
Russian Federation | |
Multiple Locations, Russian Federation | |
Slovakia | |
Multiple Locations, Slovakia | |
Slovenia | |
Multiple Locations, Slovenia | |
Sweden | |
Multiple Locations, Sweden | |
Ukraine | |
Multiple Locations, Ukraine | |
United Kingdom | |
Multiple Locations, United Kingdom |
Study Director: | Bayer Study Director | Bayer |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Bayer |
ClinicalTrials.gov Identifier: | NCT01606995 |
Other Study ID Numbers: |
15914 XA1101 ( Other Identifier: Company internal ) |
First Posted: | May 28, 2012 Key Record Dates |
Last Update Posted: | August 3, 2022 |
Last Verified: | July 2022 |
Stroke Embolism Atrial fibrillation |
Atrial Fibrillation Cardiovascular Diseases Arrhythmias, Cardiac Heart Diseases Pathologic Processes Rivaroxaban Factor Xa Inhibitors |
Antithrombins Serine Proteinase Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anticoagulants |