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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01925755
Acronym
NEURO-XAR
Enrollment
209
Registered
2013-08-20
Start date
2013-07-31
Completion date
2015-07-31
Last updated
2017-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Embolism, Stroke

Keywords

Non-interventional, Rivaroxaban, Prevention in prior stroke or TIA, Russian Federation

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.

Interventions

OTHERRivaroxaban ( 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

Sponsors

Janssen Research & Development, LLC
CollaboratorINDUSTRY
Bayer
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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 rivaroxabanup 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

MeasureTime frameDescription
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 monthsCHA2DS2 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 practiceup to 6 months
Describe AE characteristics (frequency, severity, relation to treatment, AE treatment, AE outcome)up to 6 months

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026