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

NCT01855139 | Completed

• 2 other identifiers: 16851XA1313BE
• Study Type: observational
• Target: 106
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atrial Fibrillation

Keywords

Non-valvular atrial fibrillation; Stroke; Systemic embolism; Oral anticoagulation; Real-life setting; Preventive measure

Outcome Measures

Primary Outcomes (6)

• Number of patients with major bleedings

  1 year or 30 days after end of rivaroxaban

• Number of patients with symptomatic thromboembolic events

  1 year or 30 days after end of rivaroxaban

• All-cause mortality

  1 year or 30 days after end of rivaroxaban

• Adverse events

  1 year or 30 days after end of rivaroxaban

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

  1 year or 30 days after end of rivaroxaban

• Quantities of resource use consumption

  1 year or 30 days after end of rivaroxaban

Study Arms (1)

Rivaroxaban

Drug: Rivaroxaban (Xarelto, BAY59-7939)

Interventions

Rivaroxaban (Xarelto, BAY59-7939) DRUG

15 mg OD or 20 mg OD

Rivaroxaban

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Ambulatory or hospitalized patients coming from the cardiology clinic of the participating hospitals

You may qualify if:

• 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

You may not qualify if:

• Patients who do not fulfil the Belgian reimbursement criteria

Sponsors & Collaborators

• Bayer: lead
• Janssen Scientific Affairs, LLC: collaborator

Study Sites (1)

Unknown Facility

Many Locations, Belgium

Location

MeSH Terms

Conditions

Atrial Fibrillation; Stroke

Interventions

Rivaroxaban

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2013
• First Posted: May 16, 2013
• Study Start: July 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: December 1, 2014
• Last Updated: January 18, 2017

Record last verified: 2017-01

Locations

BE (1)