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

Stroke Clinical Trial

— NEURO-XAR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01925755
• Other study ID #: 16627
• Secondary ID: XA2012-01RU
• Status: Completed
• Phase: N/A
• First received: July 15, 2013
• Last updated: January 19, 2017
• Start date: July 2013
• Est. completion date: July 2015

Study information

• Verified date: January 2017
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 209
• Est. completion date: July 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Embolism
• Stroke

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Janssen Research & Development, LLC

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	up to 6 months
Secondary	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)	up to 6 months
Secondary	Identify time of start of anticoagulation therapy immediately after event (stroke or TIA) for secondary prevention in real life practice		up to 6 months
Secondary	Describe AE characteristics (frequency, severity, relation to treatment, AE treatment, AE outcome)		up to 6 months

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