Xarelto for Prevention of Stroke in Patients With Atrial Fibrillation in Latinamerica and EMEA Region

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

2101 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-14

Study Completion Date

2016-06-20

Brief Summary

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This international study is a prospective noninterventional observational cohort study of patients with non-valvular atrial fibrillation who are prescribed rivaroxaban under routine treatment conditions to prevent stroke or non-central nervous system systemic embolism. Patients will be followed up for 1 year or until 30 days after end of rivaroxaban therapy in case of therapy was discontinued earlier than 12 months. Serious adverse events will be followed up adequately. Laboratory values (e.g., Hb, HCT, haemoccult) should be documented for each point in time they were measured.

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Detailed Description

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Conditions

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Atrial Fibrillation

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 DRUG

Patients with non-valvular atrial fibrillation who are prescribed Rivaroxaban under routine treatment conditions to prevent stroke or non-central nervous system systemic embolism. Decision regarding dose and duration of treatment made at the discretion of the attending investigator.

Interventions

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Rivaroxaban (Xarelto, BAY59-7939)

Patients with non-valvular atrial fibrillation who are prescribed Rivaroxaban under routine treatment conditions to prevent stroke or non-central nervous system systemic embolism. Decision regarding dose and duration of treatment made at the discretion of the attending investigator.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Female and male patients ≥ 18 years of age with a diagnosis of non-valvular atrial fibrillation who start treatment with rivaroxaban to prevent stroke or non-CNS systemic embolism, and who consent to participate in the study.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

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, , Argentina

Site Status

Many Locations, , Azerbaijan

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Many Locations, , Bahrain

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Many Locations, , Chile

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Many Locations, , Colombia

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Many Locations, , Egypt

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Many Locations, , Georgia

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ManyLocations, , Jordan

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Many Locations, , Kazakhstan

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Many Locations, , Kenya

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ManyLocations, , Lebanon

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Many Locations, , Mexico

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Many Locations, , Russia

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ManyLocations, , Saudi Arabia

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Many Locations, , United Arab Emirates

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Many Locations, , Uruguay

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Many Locations, , Venezuela

Site Status

Countries

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Argentina Azerbaijan Bahrain Chile Colombia Egypt Georgia Jordan Kazakhstan Kenya Lebanon Mexico Russia Saudi Arabia United Arab Emirates Uruguay Venezuela