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

Sponsor

Bayer (Industry)

Overall Status

Completed

CT.gov ID

NCT01925755

Collaborator

Janssen Research & Development, LLC (Industry)

209

Enrollment

Location

Duration (Months)

8.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke Embolism	Other: Rivaroxaban ( Xarelto, BAY59-7939)

Study Design

Study Type:

Observational

Actual Enrollment :

209 participants

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

Study Start Date :

Jul 1, 2013

Actual Primary Completion Date :

Jan 1, 2015

Actual Study Completion Date :

Jul 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

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 [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) [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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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