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

Atrial Fibrillation Clinical Trial

— XaMINA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03284762
• Other study ID #: 18981
• Status: Completed
• Start date: September 11, 2017
• Est. completion date: November 20, 2019

Study information

• Verified date: November 2020
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1216
• Est. completion date: November 20, 2019
• Est. primary completion date: August 9, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Embolism

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

Locations

Country	Name	City	State
Korea, Republic of	Different facilities	Multiple Locations
Taiwan	Different facilities	Multiple Locations

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Janssen Research & Development, LLC

Countries where clinical trial is conducted

Korea, Republic of,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major bleeding events, collected as Serious Adverse Events (SAEs) or non-serious Adverse Events (AEs)	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	AEs	All events which do not fall under characterization of major bleeding events as explained in section "primary outcome variables"	Up to one year
Secondary	SAEs	All events which do not fall under characterization of major bleeding events as explained in section "primary outcome variables"	Up to one year
Secondary	All-cause mortality	All events which do not fall under characterization of major bleeding events as explained in section "primary outcome variables"	Up to one year
Secondary	Non-major bleeding events	All events which do not fall under characterization of major bleeding events as explained in section "primary outcome variables"	Up to one year
Secondary	Symptomatic thromboembolic events	All events which do not fall under characterization of major bleeding events as explained in section "primary outcome variables"	Up to one year
Secondary	Start of rivaroxaban therapy and, if applicable, stop of rivaroxaban therapy	Start date and stop date will be collected to receive information on drug persistence	Up to one year

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