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 August 2014 by Bayer
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01925755
First received: July 15, 2013
Last updated: August 26, 2014
Last verified: August 2014
  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.


Condition Intervention
Stroke,
Embolism
Other: Rivaroxaban ( Xarelto, BAY59-7939)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Multicenter Observational Non-interventional Local Study on Prescription Behavior of Anticoagulation Therapy in Secondary Stroke Prevention in Atrial Fibrillation Patients

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 214
Study Start Date: July 2013
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01925755

Contacts
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com

Locations
Russian Federation
Recruiting
Many locations, Russian Federation
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01925755     History of Changes
Other Study ID Numbers: 16627, XA2012-01RU
Study First Received: July 15, 2013
Last Updated: August 26, 2014
Health Authority: Russia: Ethics Committee

Keywords provided by Bayer:
Non-interventional
Rivaroxaban
Prevention in prior stroke or TIA
Russian Federation

Additional relevant MeSH terms:
Atrial Fibrillation
Embolism
Stroke
Cerebral Infarction
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Brain Infarction
Brain Ischemia
Rivaroxaban
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014