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Completed

NCT Number: NCT01855139

Belgian Real Life Non-interventional Study (NIS) on Xarelto in Non-valvular Atrial Fibrillation (AF) Patients Treated for the Prevention of Stroke and Systemic Embolism

The objective of this NIS is to assess in a real-life setting, usage patterns and associated outcomes in the management (healthcare resource utilisation and associated costs) of patients with non-valvular AF treated with Xarelto, in accordance with the terms of the European marketing authorization and the Belgian reimbursement criteria.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Heart Diseases Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients ≥ 18 years old with a confirmed diagnosis of non-valvular atrial fibrillation
  • Patients must in addition present with at least one of following risk factors:
  • prior stroke, TIA (transient ischemic attack) or non-CNS (central nervous system) systemic embolism
  • left ventricular ejection fraction of < 40%
  • symptomatic heart failure, New York Heart Association class 2 or higher
  • age ≥75 years
  • age ≥65 years in combination with either diabetes, coronary disease or arterial hypertension

Exclusion criteria

  • Patients who do not fulfil the Belgian reimbursement criteria

Treatment and study plan

Rivaroxaban (Xarelto, BAY59-7939)

Drug

15 mg OD or 20 mg OD

Primary outcomes

  1. Number of patients with major bleedings

    Time frame: 1 year or 30 days after end of rivaroxaban

  2. Number of patients with symptomatic thromboembolic events

    Time frame: 1 year or 30 days after end of rivaroxaban

  3. All-cause mortality

    Time frame: 1 year or 30 days after end of rivaroxaban

  4. Adverse events

    Time frame: 1 year or 30 days after end of rivaroxaban

  5. Treatment satisfaction measured by means of Anti-clot treatment scale (ACTS)

    Time frame: 1 year or 30 days after end of rivaroxaban

  6. Quantities of resource use consumption

    Time frame: 1 year or 30 days after end of rivaroxaban

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

  • Janssen Scientific Affairs, LLC

Registry information

Official study title

Belgian Real Life Non-interventional Study (NIS) on Xarelto® in Non-valvular Atrial Fibrillation (AF) Patients Treated for the Prevention of Stroke and Systemic Embolism (BOX-AF)

Acronym: BOX-AF

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
May 16, 2013
Registry last updated
Jan 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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