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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
Health authority
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

Study Design


Related Conditions & MeSH terms


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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