NCT01606995

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.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,784

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2012

Typical duration for all trials

Geographic Reach
20 countries

20 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 24, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 28, 2012

Completed
15 days until next milestone

Study Start

First participant enrolled

June 12, 2012

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 6, 2015

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2015

Completed
Last Updated

August 3, 2022

Status Verified

July 1, 2022

Enrollment Period

2.7 years

First QC Date

May 24, 2012

Last Update Submit

August 1, 2022

Conditions

Atrial Fibrillation

Keywords

StrokeEmbolismAtrial fibrillation

Outcome Measures

Primary Outcomes (2)

  • Adjudicated major bleeding events

    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

    after 1 year or until 30 days after end of rivaroxaban therapy

Secondary Outcomes (3)

  • All cause mortality

    after 1 year or until 30 days after end of rivaroxaban therapy

  • Adjudicated symptomatic thromboembolic events

    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

    after 1 year or until 30 days after end of rivaroxaban therapy

Study Arms (1)

Group 1

Drug: Rivaroxaban (Xarelto, BAY59-7939)

Interventions

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

Group 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with a diagnosis of non-valvular atrial fibrillation who start treatment with rivaroxaban to prevent stroke or non-CNS systemic embolism

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

Unknown Facility

Multiple Locations, Austria

Location

Unknown Facility

Multiple Locations, Belgium

Location

Unknown Facility

Multiple Locations, Canada

Location

Unknown Facility

Multiple Locations, Czechia

Location

Unknown Facility

Multiple Locations, Denmark

Location

Unknown Facility

Multiple Locations, France

Location

Unknown Facility

Multiple Locations, Germany

Location

Unknown Facility

Multiple Locations, Hungary

Location

Unknown Facility

Multiple Locations, Ireland

Location

Unknown Facility

Multiple Locations, Israel

Location

Unknown Facility

Multiple Locations, Moldova

Location

Unknown Facility

Multiple Locations, Netherlands

Location

Unknown Facility

Multiple Locations, Norway

Location

Unknown Facility

Multiple Locations, Poland

Location

Unknown Facility

Multiple Locations, Portugal

Location

Unknown Facility

Multiple Locations, Russia

Location

Unknown Facility

Multiple Locations, Slovakia

Location

Unknown Facility

Multiple Locations, Slovenia

Location

Unknown Facility

Multiple Locations, Sweden

Location

Unknown Facility

Multiple Locations, Ukraine

Location

Unknown Facility

Multiple Locations, United Kingdom

Location

Related Publications (7)

  • 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.

    PMID: 38941511DERIVED

  • 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.

    PMID: 32079476DERIVED

  • 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.

    PMID: 30423165DERIVED

  • 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.

    PMID: 29976287DERIVED

  • 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.

    PMID: 29016755DERIVED

  • 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.

    PMID: 26330425DERIVED

  • 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.

    PMID: 25083135DERIVED

Related Links

MeSH Terms

Conditions

Atrial FibrillationStrokeEmbolism

Interventions

Rivaroxaban

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesEmbolism and Thrombosis

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsMorpholinesOxazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2012

First Posted

May 28, 2012

Study Start

June 12, 2012

Primary Completion

March 6, 2015

Study Completion

March 31, 2015

Last Updated

August 3, 2022

Record last verified: 2022-07

Locations

PT(1)SL(1)PL(1)BE(1)AU(1)NL(1)GB(1)RU(1)CA(1)FR(1)HU(1)IL(1)DE(1)MO(1)UA(1)CZ(1)IE(1)DK(1)NO(1)SE(1)