NCT01750788

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
2,297

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2013

Typical duration for all trials

Geographic Reach
11 countries

11 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

December 13, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 17, 2012

Completed
27 days until next milestone

Study Start

First participant enrolled

January 13, 2013

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 12, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 12, 2015

Completed
Last Updated

September 21, 2017

Status Verified

September 1, 2017

Enrollment Period

2.7 years

First QC Date

December 13, 2012

Last Update Submit

September 20, 2017

Conditions

Atrial Fibrillation

Keywords

StrokeEmbolismAtrial Fibrillation

Outcome Measures

Primary Outcomes (3)

  • Adjudicated major bleeding events

    after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later

  • 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, whichever is later

  • All cause mortality

    after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later

Secondary Outcomes (8)

  • Adjudicated symptomatic thromboembolic events

    after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later

  • Non-major bleeding, collected as SAEs or non-serious AEs and defined as all bleeding events that do not fall in the category of major bleedings

    after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later

  • Treatment satisfaction as per patient assessment of rivaroxaban treatment by the physician at the final visit

    after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later

  • Healthcare resource

    after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later

  • Adverse events rates in the different AF risk factor categories

    after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later

  • +3 more secondary outcomes

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 (11)

Unknown Facility

Many Locations, Hong Kong

Location

Unknown Facility

Many Locations, India

Location

Unknown Facility

Many Locations, Indonesia

Location

Unknown Facility

Many Locations, Malaysia

Location

Unknown Facility

Many Locations, Pakistan

Location

Unknown Facility

Many Locations, Philippines

Location

Unknown Facility

Many Locations, Singapore

Location

Unknown Facility

Many Locations, South Korea

Location

Unknown Facility

Many Locations, Taiwan

Location

Unknown Facility

Many Locations, Thailand

Location

Unknown Facility

Many Locations, Vietnam

Location

Related Publications (2)

  • 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, 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

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

December 13, 2012

First Posted

December 17, 2012

Study Start

January 13, 2013

Primary Completion

October 12, 2015

Study Completion

October 12, 2015

Last Updated

September 21, 2017

Record last verified: 2017-09

Locations

PA(1)IN(1)ID(1)VN(1)TH(1)KR(1)TW(1)HK(1)PH(1)SG(1)MY(1)