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Completed

NCT Number: NCT01925755

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.

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Key information

Conditions

Stroke Brain Diseases Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Embolism Embolism and Thrombosis Ischemic Attack, Transient Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations, Russia

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Rivaroxaban ( Xarelto, BAY59-7939)

Other

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

Primary outcomes

  1. 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 outcomes

  1. 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)

  2. 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

  3. Describe AE characteristics (frequency, severity, relation to treatment, AE treatment, AE outcome)

    Time frame: up to 6 months

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

  • Janssen Research & Development, LLC

Registry information

Official study title

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

Acronym: NEURO-XAR

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Aug 20, 2013
Registry last updated
Jan 23, 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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