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

Recruiting

Phase N/A Results N/A

Trial Description

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.

Conditions

Interventions

  • Rivaroxaban (Xarelto, BAY59-7939) Drug
    Intervention Desc: 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 1: Kind: Experimental
    Label: Treatment-naïve NVAF patients in Korea and Taiwan
    Description: Patients will be followed according to routine medical practice and the frequency of visits and procedures will be performed under routine conditions

Trial Population

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

Outcomes

Type Measure Time Frame Safety Issue
Primary Major bleeding events, collected as Serious Adverse Events (SAEs) or non-serious Adverse Events (AEs) Up to one year
Secondary AEs Up to one year
Secondary SAEs Up to one year
Secondary All-cause mortality Up to one year
Secondary Non-major bleeding events Up to one year
Secondary Symptomatic thromboembolic events Up to one year
Secondary Start of rivaroxaban therapy and, if applicable, stop of rivaroxaban therapy Up to one year

Sponsors