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

N/ACompletedNCT01925755

Bayer209 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

209

Conditions

Stroke Embolism

Interventions

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Many Locations, Russia

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 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

Time frame: up to 6 months

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)

CHA2DS2 VASC - Stroke risk assessment scale; HAS BLED - Score for Major Bleeding Risk (in anticoagulation therapy)

Time frame: 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

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

Time frame: up to 6 months

Data from ClinicalTrials.gov

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