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

Completed

• Conditions: Stroke; Embolism
• Interventions: Other: Rivaroxaban ( Xarelto, BAY59-7939)

• Registration Number: NCT01925755
• Lead Sponsor: Bayer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-07-15
• Study First Submitted QC: 2013-08-16
• Study First Posted: 2013-08-20
• Primary Completion: 2015-01
• Study Completion: 2015-07
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-19
• Last Update Posted: 2017-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 209

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Rivaroxaban ( Xarelto, BAY59-7939)	-

Primary Outcome Measures

Name	Time	Method
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	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

Name	Time	Method
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	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	up to 6 months
Describe AE characteristics (frequency, severity, relation to treatment, AE treatment, AE outcome)	up to 6 months