Evaluation of Effectiveness and Safety of Xa Inhibitor for the Prevention of Stroke And Systemic Embolism in a Nationwide Cohort of Japanese Patients Diagnosed as Non-valvular Atrial Fibrillation

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

UNKNOWN

Total Enrollment

7000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-11-30

Brief Summary

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The efficacy and safety of a novel oral Xa inhibitor for stroke and systemic embolism, namely rivaroxaban, in non-valvular atrial fibrillation patients are evaluated in Japanese clinical practice.

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Detailed Description

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Conditions

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Non-valvular Atrial Fibrillation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Non-valvular atrial fibrillation

* Patients diagnosed with non-valvular atrial fibrillation
* Patients who are treated or will be treated with rivaroxaban

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

Patients who meet all the criteria below

* Patients aged over 20 years
* Patients diagnosed with non-valvular atrial fibrillation
* Patients who are treated or will be treated with rivaroxaban
* Patients from whom written informed consent has been obtained

Exclusion Criteria

Patients who meet any of the criteria below

* The following patients in whom rivaroxaban is contraindicated for use
* Patients with a history of allergies to the ingredients contained in this drug
* Patients having a hemorrhagic event (intracranial hemorrhage, gastrointestinal hemorrhage or other clinically significant hemorrhagic events)
* Patients having liver disease complicated with coagulation disorder or those having moderate or worse liver disorder (Grade B or C in accordance with the Child-Pugh classification)
* Patients having renal failure (creatinine clearance: \<15 mL/min)
* Women who are or are likely to be pregnant
* Patients who are treated with HIV protease inhibitors (including ritonavir, atazanavir and indinavir)
* Patients who are treated with oral or injectable formulations of azole antifungal drugs (including itraconazole, voriconazole and ketoconazole (excluding fluconazole))

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No