Xarelto on Prevention of Stroke and Noncentral Nervous System Systemic Embolism in Treatment-naïve Asian Patients With Non-valvular Atrial Fibrillation (XaMINA)

November 20, 2020 updated by: Bayer

Xarelto® on Prevention of Stroke and Noncentral Nervous System systeMIc Embolism in Treatment Naïve Asian Patients With Non-valvular Atrial Fibrillation

The purpose of the study is to collect additional information of Xarelto treatment in routine clinical practice. Patients affected by atrial fibrillation and who will get Xarelto as a prophylactic treatment against stroke and systemic embolism (Stroke Prevention in Atrial Fibrillation) will be observed.

Study Overview

Status

Completed

Conditions

Detailed Description

The study takes place in Korea and Taiwan. Approximately a total of 1200 patients will be included in the study within 12 months. The observation period for each patient is 1 year from enrollment into the study, or until withdrawal of consent or lost to follow-up. Patients will be followed according to routine medical practice and the frequency of visits and procedures will be performed under routine conditions.

Study Type

Observational

Enrollment (Actual)

1216

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Multiple Locations, Korea, Republic of
        • Different facilities
      • Multiple Locations, Taiwan
        • Different facilities

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients from Taiwan and Korea visiting doctors in hospitals or medical practices for treatment of atrial fibrillation

Description

Inclusion Criteria:

  • Female and male patients aged 19 years or older (Korea) and aged 20 years or older (Taiwan)
  • Diagnosis of NVAF
  • Patients for whom the decision to initiate treatment with rivaroxaban is made as per physician's routine treatment practice
  • Treatment naïve regarding stroke prevention for atrial fibrillation
  • Signed informed consent

Exclusion Criteria:

  • Contraindications for rivaroxaban according to the local market authorization/summary of product characteristics (SmPC)
  • Patients participating in an investigational program with interventions outside of routine clinical practice

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Treatment-naïve NVAF patients in Korea and Taiwan
Patients will be followed according to routine medical practice and the frequency of visits and procedures will be performed under routine conditions. NVAF: Non-valvular atrial fibrillation
Rivaroxaban is a direct Factor Xa inhibitor. In this non-interventional setting, the prescription and dosing scheme is up to the treatment physician, however, the recommended dosing scheme is 20mg/day (once daily) or 15 mg/day (once daily) in patients with reduced renal function

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major bleeding events, collected as Serious Adverse Events (SAEs) or non-serious Adverse Events (AEs)
Time Frame: Up to one year

Major bleeding events, collected as SAEs or non-serious AEs and defined as overt bleeding associated with:

  • A fall in hemoglobin of ≥2 g/dL, or
  • A transfusion of ≥2 units of packed red blood cells or whole blood, or
  • Occurrence at a critical site (intracranial, intra-spinal, intraocular, pericardial, intra articular, intra-muscular with compartment syndrome, retroperitoneal), or
  • Death.
Up to one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AEs
Time Frame: Up to one year
All events which do not fall under characterization of major bleeding events as explained in section "primary outcome variables"
Up to one year
SAEs
Time Frame: Up to one year
All events which do not fall under characterization of major bleeding events as explained in section "primary outcome variables"
Up to one year
All-cause mortality
Time Frame: Up to one year
All events which do not fall under characterization of major bleeding events as explained in section "primary outcome variables"
Up to one year
Non-major bleeding events
Time Frame: Up to one year
All events which do not fall under characterization of major bleeding events as explained in section "primary outcome variables"
Up to one year
Symptomatic thromboembolic events
Time Frame: Up to one year
All events which do not fall under characterization of major bleeding events as explained in section "primary outcome variables"
Up to one year
Start of rivaroxaban therapy and, if applicable, stop of rivaroxaban therapy
Time Frame: Up to one year
Start date and stop date will be collected to receive information on drug persistence
Up to one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 11, 2017

Primary Completion (Actual)

August 9, 2019

Study Completion (Actual)

November 20, 2019

Study Registration Dates

First Submitted

September 14, 2017

First Submitted That Met QC Criteria

September 14, 2017

First Posted (Actual)

September 15, 2017

Study Record Updates

Last Update Posted (Actual)

November 24, 2020

Last Update Submitted That Met QC Criteria

November 20, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, time point and process of data access. As such, Bayer commits to sharing upon request from qualified researcher's patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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