Study Completed

Stroke, Embolism

Bayer Identifier:

16627

ClinicalTrials.gov Identifier:

NCT01925755

EudraCT Number:

Not Available

EU CT Number:

Not Available

Non-interventional local study on prescription behavior of anticoagulation therapy in secondary stroke prevention in atrial fibrillation patients

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.

Key Participants Requirements

Sex

Both

Age

18 - N/A

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

Trial summary

Enrollment Goal

209

Trial Dates

July 2013 - July 2015

Phase

N/A

Could I Receive a placebo

Products

Xarelto (Rivaroxaban, BAY59-7939)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed		Many locations, Russia

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 use
Time Frame:
up to 6 months
Safety Issue:
No

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)
Time Frame:
up to 6 months
Safety Issue:
No
Identify time of start of anticoagulation therapy immediately after event (stroke or TIA) for secondary prevention in real life practice
Time Frame:
up to 6 months
Safety Issue:
No
Describe AE characteristics (frequency, severity, relation to treatment, AE treatment, AE outcome)
Time Frame:
up to 6 months
Safety Issue:
Yes

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

N/A

Additional Information

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