Xarelto for Prevention of Stroke in Patients With Atrial Fibrillation in Asia "XANAP"

Completed

Phase N/A Results N/A

Trial Description

This is an international observational study in patients with non-valvular atrial fibrillation who are prescribed rivaroxaban under routine treatment conditions to prevent stroke or non-central nervous system systemic embolism.

Conditions

Interventions

  • Rivaroxaban (Xarelto, BAY59-7939) Drug
    Intervention Desc: Patients with non-valvular atrial fibrillation who are prescribed rivaroxaban under routine treatment conditions to prevent stroke or non-central nervous system systemic embolism. Decision regarding dose and duration of treatment made at the discretion of the attending investigator.
    ARM 1: Kind: Experimental
    Label: Group 1

Trial Design

  • Observation: Cohort
  • Perspective: Prospective
  • Sampling: Probability Sample

Trial Population

Patients with a diagnosis of non-valvular atrial fibrillation who start treatment with rivaroxaban to prevent stroke or non-CNS systemic embolism

Outcomes

Type Measure Time Frame Safety Issue
Primary Adjudicated major bleeding events after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later Yes
Primary Safety variables will be summarized using descriptive statistics based on adverse events collection after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later Yes
Secondary All cause mortality after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later Yes
Secondary Adjudicated symptomatic thromboembolic events after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later Yes
Secondary Non-major bleeding, collected as SAEs or non-serious AEs and defined as all bleeding events that do not fall in the category of major bleedings after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
Secondary Treatment satisfaction as per patient assessment of rivaroxaban treatment by the physician at the final visit after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
Secondary Healthcare resource after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
Secondary Adverse events rates in the different AF risk factor categories after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
Secondary Persistence with rivaroxaban treatment measured as percentage of patients on rivaroxaban treatment at 1 year after start of study treatment after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
Secondary Reasons for switch of rivaroxaban treatment as per physician assessment during or at end of study after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
Secondary Reasons for interruption of rivaroxaban treatment as per physician assessment during or at end of study after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later

Sponsors