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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Bayer
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01925755
First received: July 15, 2013
Last updated: July 25, 2014
Last verified: July 2014

July 15, 2013
July 25, 2014
July 2013
January 2015   (final data collection date for primary outcome measure)
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 Frame: up to 6 months ] [ Designated as safety issue: No ]
  • 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
Same as current
Complete list of historical versions of study NCT01925755 on ClinicalTrials.gov Archive Site
  • 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) [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]
    CHA2DS2 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 practice [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]
  • Describe AE characteristics (frequency, severity, relation to treatment, AE treatment, AE outcome) [ Time Frame: up to 6 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Male and female patients ≥ 18 years old with prior stroke or TIA history and who have never taken anticoagulation treatment regarding AF before and meet criteria of inclusion and exclusion.

  • Stroke,
  • Embolism
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
Group 1
Intervention: Other: Rivaroxaban ( Xarelto, BAY59-7939)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
214
July 2015
January 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com
Russian Federation
 
NCT01925755
16627, XA2012-01RU
No
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP