Protocol No: ECCT/14/03/02 Date of Protocol: 16-11-2012

Study Title:

XANTUS-EL, Xarelto on prevention of stroke and non-central nervous system systemic embolism in patients with non valvular atrial fibrillation - a non interventional study, XA 1206 (IMPACT No. 16691)

 

Study Objectives:
Laymans Summary:
Abstract of Study:

Atrial fibrillation (AF) is the most common cardiac arrhythmia of clinical significance, and is an important independent risk factor for cardiogenic thromboembolic events. Oral anticoagulant therapy is highly effective for prevention of stroke in patients with atrial fibrillation. Vitamin K antagonists (VKA) have been the standard of care over the last decades.

Rivaroxaban is a potent and selective direct Factor Xa (FXa) inhibitor and, in contrast to VKAs, can be given as fixed oral dosing without need for routine coagulation monitoring.

This non-interventional study is a prospective observational cohort study of patients with non-valvular atrial fibrillation who are prescribed Rivaroxaban, 15 mg and 20 mg tablets under routine treatment conditions to prevent stroke or non-central nervous system systemic embolism.

 Inclusion criteria is Female and Male patients, who are at least 18 years of age with a diagnosis of non valvular atrial fibrillation, who consent  to participate in the study will be enrolled after the decision for a pharmacologic prophylaxis with Rivaroxaban within approved indication per country to prevent stroke or non-CNS systemic embolism has been made.

 Patients will be followed up for 1 year or until 30 days after end of Rivaroxaban therapy in case therapy was discontinued earlier than 12 months.

Each patient per site, treated to prevent stroke or non-CNS systemic embolism, must be consecutively screened and documented in a patient log file. No patient specific data will be documented in the patient log file.

Female and male patients ≥ 18 years of age with a diagnosis of non-valvular atrial fibrillation who start treatment with Rivaroxaban to prevent stroke or non-CNS systemic embolism, and who consent to participate in the study. Prior anticoagulation therapy will be recorded in the CRF. All contra-indications according to the local marketing authorization should be considered. The main goal of this non-interventional study is to confirm the known safety profile of Rivaroxaban in clinical practice use.

The end of the study will be reached 12 months after enrolment has ended.