Xarelto for Prevention of Stroke in Patients With Atrial Fibrillation

NCT ID: NCT01606995

Last Updated: 2022-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

6784 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-06-12

Study Completion Date

2015-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

Rivaroxaban (Xarelto, BAY59-7939)

Intervention Type 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

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Janssen Research & Development, LLC

INDUSTRY

Sponsor Role collaborator

Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Multiple Locations, , Austria

Site Status

Multiple Locations, , Belgium

Site Status

Multiple Locations, , Canada

Site Status

Multiple Locations, , Czechia

Site Status

Multiple Locations, , Denmark

Site Status

Multiple Locations, , France

Site Status

Multiple Locations, , Germany

Site Status

Multiple Locations, , Hungary

Site Status

Multiple Locations, , Ireland

Site Status

Multiple Locations, , Israel

Site Status

Multiple Locations, , Moldova

Site Status

Multiple Locations, , Netherlands

Site Status

Multiple Locations, , Norway

Site Status

Multiple Locations, , Poland

Site Status

Multiple Locations, , Portugal

Site Status

Multiple Locations, , Russia

Site Status

Multiple Locations, , Slovakia

Site Status

Multiple Locations, , Slovenia

Site Status

Multiple Locations, , Sweden

Site Status

Multiple Locations, , Ukraine

Site Status

Multiple Locations, , United Kingdom

Site Status

Countries

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

References

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Kirchhof P, Haas S, Amarenco P, Turpie AGG, Bach M, Lambelet M, Hess S, Camm AJ. Causes of death in patients with atrial fibrillation anticoagulated with rivaroxaban: a pooled analysis of XANTUS. Europace. 2024 Jul 2;26(7):euae183. doi: 10.1093/europace/euae183.

Reference Type DERIVED
PMID: 38941511 (View on PubMed)

Kirchhof P, Haas S, Amarenco P, Hess S, Lambelet M, van Eickels M, Turpie AGG, Camm AJ; XANTUS Investigators*. Impact of Modifiable Bleeding Risk Factors on Major Bleeding in Patients With Atrial Fibrillation Anticoagulated With Rivaroxaban. J Am Heart Assoc. 2020 Mar 3;9(5):e009530. doi: 10.1161/JAHA.118.009530. Epub 2020 Feb 21.

Reference Type DERIVED
PMID: 32079476 (View on PubMed)

Amarenco P, Haas S, Hess S, Kirchhof P, Lambelet M, Bach M, Turpie AGG, Camm AJ. Outcomes associated with non-recommended dosing of rivaroxaban: results from the XANTUS study. Eur Heart J Cardiovasc Pharmacother. 2019 Apr 1;5(2):70-79. doi: 10.1093/ehjcvp/pvy041.

Reference Type DERIVED
PMID: 30423165 (View on PubMed)

Kirchhof P, Radaideh G, Kim YH, Lanas F, Haas S, Amarenco P, Turpie AGG, Bach M, Lambelet M, Hess S, Camm AJ; Global XANTUS program Investigators. Global Prospective Safety Analysis of Rivaroxaban. J Am Coll Cardiol. 2018 Jul 10;72(2):141-153. doi: 10.1016/j.jacc.2018.04.058.

Reference Type DERIVED
PMID: 29976287 (View on PubMed)

Camm AJ, Turpie AGG, Hess S, Amarenco P, Lambelet M, Haas S, van Eickels M, Kirchhof P; XANTUS Investigators. Outcomes after catheter ablation and cardioversion in patients with non-valvular atrial fibrillation: results from the prospective, observational XANTUS study. Europace. 2018 Jun 1;20(6):e87-e95. doi: 10.1093/europace/eux127.

Reference Type DERIVED
PMID: 29016755 (View on PubMed)

Camm AJ, Amarenco P, Haas S, Hess S, Kirchhof P, Kuhls S, van Eickels M, Turpie AG; XANTUS Investigators. XANTUS: a real-world, prospective, observational study of patients treated with rivaroxaban for stroke prevention in atrial fibrillation. Eur Heart J. 2016 Apr 7;37(14):1145-53. doi: 10.1093/eurheartj/ehv466. Epub 2015 Sep 1.

Reference Type DERIVED
PMID: 26330425 (View on PubMed)

Camm AJ, Amarenco P, Haas S, Hess S, Kirchhof P, van Eickels M, Turpie AG. XANTUS: rationale and design of a noninterventional study of rivaroxaban for the prevention of stroke in patients with atrial fibrillation. Vasc Health Risk Manag. 2014 Jul 17;10:425-34. doi: 10.2147/VHRM.S63298. eCollection 2014.

Reference Type DERIVED
PMID: 25083135 (View on PubMed)

Related Links

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http://clinicaltrials.bayer.com/

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Other Identifiers

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XA1101

Identifier Type: OTHER

Identifier Source: secondary_id

15914

Identifier Type: -

Identifier Source: org_study_id

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