Xarelto for Prevention of Stroke in Patients With Atrial Fibrillation in Latinamerica and EMEA Region "XANTUS-EL"

Completed

Phase N/A Results N/A

Trial Description

This international study is a prospective noninterventional observational cohort study of patients with non-valvular atrial fibrillation who are prescribed rivaroxaban under routine treatment conditions to prevent stroke or non-central nervous system systemic embolism. Patients will be followed up for 1 year or until 30 days after end of rivaroxaban therapy in case of therapy was discontinued earlier than 12 months. Serious adverse events will be followed up adequately. Laboratory values (e.g., Hb, HCT, haemoccult) should be documented for each point in time they were measured.

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 non-valvular atrial fibrillation who are prescribed rivaroxaban under routine treatment conditions to prevent stroke or noncentral nervous system 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
Primary Safety variables will be summarized using descriptivestatistics based on adverse events collection 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 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 after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
Secondary Reasons for switch of rivaroxaban treatment after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
Secondary Reasons for interruption of rivaroxaban treatment 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

Sponsors