Non-interventional Local Study on Prescription Behavior of Anticoagulation Therapy in Secondary Stroke Prevention in Atrial Fibrillation Patients (NEURO-XAR)

January 19, 2017 updated by: Bayer

Prospective Multicenter Observational Non-interventional Local Study on Prescription Behavior of Anticoagulation Therapy in Secondary Stroke Prevention in Atrial Fibrillation Patients

This is local prospective multicenter observational non-interventional local study. Primary study objective is investigate and describe prescription pattern of neurologists in secondary stroke or non-CNS (non-Central Nervous System) systemic embolism prevention in patients with AF (Atrial fibrillation) and prior stroke or TIA (Transient Ischemic attack) who treat with rivaroxaban at an initial visit and three follow-up visits.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

209

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Male and female patients ≥ 18 years old with prior stroke or TIA history and who have never taken anticoagulation treatment regarding AF before and meet criteria of inclusion and exclusion.

Description

Inclusion Criteria:

  • Male and female patients ≥ 18 years old who start treatment with rivaroxaban
  • Non-valvular Atrial Fibrillation is documented in patients' file
  • Prior TIA/Stroke history
  • TIA - more than 72 hours after documented TIA
  • more than 2 weeks after non-hemorrhagic stroke
  • Written informed consent

Exclusion Criteria:

  • Contraindications for use of Xarelto® in accordance with approved product label
  • Previous thromboprophylaxis treatment with anticoagulants prior toby reason of stroke / TIA prevention
  • Any reasons of medical and non-medical character, which in the opinion of the physician can hamper patient participation in NIS

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
Other: Rivaroxaban ( Xarelto, BAY59-7939)
Patients with prior stroke or TIA history and who have never taken anticoagulation treatment regarding AF before. One film-coated tablet contains Rivaroxaban 15 mg or 20mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prescription pattern of neurologists in secondary stroke or non-CNS systemic embolism prevention in patients with AF and prior stroke or TIA who treat with rivaroxaban
Time Frame: up to 6 months
  • Time lag after prior stroke or TIA before Xarelto prescription;
  • Frequency of switching/discontinuation of Xarelto treatment;
  • Time to switching/discontinuation of Xarelto treatment;
  • Reasons of switching/discontinuation of Xarelto treatment (using formalized criteria list);
  • In case of change of treatment - drug, dose, duration of use
up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Descriptive characteristics of patients after prior stroke/TIA in the need of secondary stroke prevention with Xarelto (gender, age, race, alcohol/smoking, BMI and BP abnormalities, CHA2DS2 VASC, HAS BLED, Rankin Score)
Time Frame: up to 6 months
CHA2DS2 VASC - Stroke risk assessment scale; HAS BLED - Score for Major Bleeding Risk (in anticoagulation therapy)
up to 6 months
Identify time of start of anticoagulation therapy immediately after event (stroke or TIA) for secondary prevention in real life practice
Time Frame: up to 6 months
up to 6 months
Describe AE characteristics (frequency, severity, relation to treatment, AE treatment, AE outcome)
Time Frame: up to 6 months
up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Collaborators

Janssen Research & Development, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

July 15, 2013

First Submitted That Met QC Criteria

August 16, 2013

First Posted (Estimate)

August 20, 2013

Study Record Updates

Last Update Posted (Estimate)

January 23, 2017

Last Update Submitted That Met QC Criteria

January 19, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16627
  • XA2012-01RU (Other Identifier: Company internal)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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