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

NCT ID: NCT01925755

Last Updated: 2017-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

209 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-07-31

Study Completion Date

2015-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Stroke Embolism

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

Rivaroxaban ( Xarelto, BAY59-7939)

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Janssen Research & Development, LLC

INDUSTRY

Sponsor Role collaborator

Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Many Locations, , Russia

Site Status

Countries

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Russia

Other Identifiers

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XA2012-01RU

Identifier Type: OTHER

Identifier Source: secondary_id

16627

Identifier Type: -

Identifier Source: org_study_id

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