We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01925755
First Posted: August 20, 2013
Last Update Posted: January 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Bayer
  Purpose
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.

Condition Intervention
Stroke Embolism Other: Rivaroxaban ( Xarelto, BAY59-7939)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Multicenter Observational Non-interventional Local Study on Prescription Behavior of Anticoagulation Therapy in Secondary Stroke Prevention in Atrial Fibrillation Patients

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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)

  • 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 ]
  • Describe AE characteristics (frequency, severity, relation to treatment, AE treatment, AE outcome) [ Time Frame: up to 6 months ]

Enrollment: 209
Study Start Date: July 2013
Study Completion Date: July 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01925755


Locations
Russian Federation
Many locations, Russian Federation
Sponsors and Collaborators
Bayer
Janssen Research & Development, LLC
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01925755     History of Changes
Other Study ID Numbers: 16627
XA2012-01RU ( Other Identifier: Company internal )
First Submitted: July 15, 2013
First Posted: August 20, 2013
Last Update Posted: January 23, 2017
Last Verified: January 2017

Keywords provided by Bayer:
Non-interventional
Rivaroxaban
Prevention in prior stroke or TIA
Russian Federation

Additional relevant MeSH terms:
Stroke
Atrial Fibrillation
Embolism
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Heart Diseases
Pathologic Processes
Embolism and Thrombosis
Rivaroxaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants