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Clinical Trials/NCT01925755
NCT01925755
Completed
Not Applicable

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

Bayer0 sites209 target enrollmentJuly 2013
ConditionsStrokeEmbolism

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Bayer
Enrollment
209
Primary Endpoint
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
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
July 2013
End Date
July 2015
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Bayer
Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

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

  • 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)(up to 6 months)
  • Identify time of start of anticoagulation therapy immediately after event (stroke or TIA) for secondary prevention in real life practice(up to 6 months)
  • Describe AE characteristics (frequency, severity, relation to treatment, AE treatment, AE outcome)(up to 6 months)

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