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

ID: NCT03284762
Status: Recruiting
Phase: N/A
Start Date: September 11, 2017
First Submitted: September 14, 2017
Last Updated: February 12, 2018
Results: N/A
Organization: Bayer
Sponsors & Collaborators: Bayer, Janssen Research & Development, LLC
Location: Korea, Republic of, Taiwan
Conditions: Atrial Fibrillation
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Study Description

Brief Summary

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.

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.
Condition or disease Intervention/treatment Phase

Atrial Fibrillation

Drug: Rivaroxaban (Xarelto, Bay59-7939)
Other Names
N/A

Tracking Information

First Submitted DateSeptember 14, 2017
Last Update Posted DateFebruary 12, 2018
Actual Start DateSeptember 11, 2017
Anticipated Completion DateSeptember 30, 2019
Actual Primary Completion DateSeptember 30, 2019
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • 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.

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • 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"

  • 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"

  • 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"

  • 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"

  • 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"

  • 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

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleXarelto on Prevention of Stroke and Noncentral Nervous System Systemic Embolism in Treatment Naïve Asian Patients With Non-valvular Atrial Fibrillation
Official TitleXarelto® on Prevention of Stroke and Noncentral Nervous System systeMIc Embolism in Treatment Naïve Asian Patients With Non-valvular Atrial Fibrillation
Brief Summary

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.

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 TypeObservational
Study PhaseN/A
Estimated Enrollment
1200
Allocation
Not Available
Interventional Model
Not Available
Masking
Not Available
Primary Purpose
Not Available
Conditions
Atrial Fibrillation
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodProbability Sample
Study PopulationPatients from Taiwan and Korea visiting doctors in hospitals or medical practices for treatment of atrial fibrillation
Intervention
Drug: Rivaroxaban (Xarelto, Bay59-7939)

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

Other Names
Study Groups/Cohorts
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

Study Arms
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
Drug : Rivaroxaban (Xarelto, Bay59-7939)
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

Arm 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
Drug : Rivaroxaban (Xarelto, Bay59-7939)

Recruitment Information

Recruitment Status:Recruiting
Enrollment1200
Completion DateSeptember 30, 2019
Eligibility Criteria: 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
GenderAll
Age19 Years to N/A
Accepts Healthy VolunteersNo
Contacts
Listed Location Countries
Korea, Republic of
Taiwan

Administrative Information

NCT Number:NCT03284762
Other Study ID Numbers
18981
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
Bayer
Collaborators
Janssen Research & Development, LLC
Investigators
Not Available