Trial Condition(s):
Stroke, Embolism
Non-interventional local study on prescription behavior of anticoagulation therapy in secondary stroke prevention in atrial fibrillation patients (NEURO-XAR)
Bayer Identifier:
16627
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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.
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 consentExclusion 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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Investigative Site Many locations, Russia | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Prospective multicenter observational non-interventional local study on prescription behavior of anticoagulation therapy in secondary stroke prevention in atrial fibrillation patients
Trial Type:
Observational
Intervention Type:
Other
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- 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 useTimeframe: up to 6 months
Secondary Outcome
- 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)Timeframe: up to 6 months
- Identify time of start of anticoagulation therapy immediately after event (stroke or TIA) for secondary prevention in real life practiceTimeframe: up to 6 months
- Describe AE characteristics (frequency, severity, relation to treatment, AE treatment, AE outcome)Timeframe: up to 6 months
Additional Information
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