Xarelto for Prevention of Stroke in Patients With Atrial Fibrillation "XANTUS"

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 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 Yes
Secondary All cause mortality after 1 year or until 30 days after end of rivaroxaban therapy Yes
Secondary Adjudicated symptomatic thromboembolic events after 1 year or until 30 days after end of rivaroxaban therapy Yes
Secondary Persistence with rivaroxaban treatment: Reasons for any switch from or interruption of rivaroxaban treatment after 1 year or until 30 days after end of rivaroxaban therapy No

Sponsors