check_circleStudy 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
  • - 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

  • - 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
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteer
No

Where to participate

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