Xarelto for Prevention of Stroke in Patients With Atrial Fibrillation in Asia (XANAP)

This study has been completed.

Sponsor:

Collaborator:

Janssen Research & Development, LLC

Information provided by (Responsible Party):

Bayer

ClinicalTrials.gov Identifier:

NCT01750788

First received: December 13, 2012

Last updated: January 19, 2017

Last verified: January 2017

History of Changes

Tracking Information

First Received Date ^ICMJE

December 13, 2012

Last Updated Date

January 19, 2017

Start Date ^ICMJE

January 2013

Primary Completion Date

October 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Adjudicated major bleeding events [ Time Frame: 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 [ Time Frame: after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01750788 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

All cause mortality [ Time Frame: after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later ]
Adjudicated symptomatic thromboembolic events [ Time Frame: after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Xarelto for Prevention of Stroke in Patients With Atrial Fibrillation in Asia

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Probability 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

Condition ^ICMJE

Atrial Fibrillation

Intervention ^ICMJE

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.

Study Groups/Cohorts

Group 1

Intervention: Drug: Rivaroxaban (Xarelto, BAY59-7939)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

2297

Completion Date

October 2015

Primary Completion Date

October 2015 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Hong Kong, India, Indonesia, Korea, Republic of, Malaysia, Pakistan, Philippines, Singapore, Taiwan, Thailand, Vietnam

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT01750788

Other Study ID Numbers ^ICMJE

16371
XA1205 ( Other Identifier: Company internal )

Has Data Monitoring Committee

U.S. FDA-regulated Product

Not Provided

Plan to Share Data

Not Provided

IPD Description

Not Provided

Responsible Party

Bayer

Study Sponsor ^ICMJE

Bayer

Collaborators ^ICMJE

Janssen Research & Development, LLC

Investigators ^ICMJE

Study Director:

Bayer Study Director

Bayer

PRS Account

Bayer

Verification Date

January 2017

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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