Skip to main content
OpenTrials
Completed

NCT Number: NCT03284762

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Different facilities, Multiple Locations, South Korea

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rivaroxaban (Xarelto, BAY59-7939)

Drug

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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"

  2. 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"

  3. 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"

  4. 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"

  5. 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"

  6. 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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

  • Janssen Research & Development, LLC

Registry information

Official study title

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

Acronym: XaMINA

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Sep 15, 2017
Registry last updated
Nov 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.