Xarelto on Prevention of Stroke and Non-Central Nervous Systemic Embolism in Renally Impaired Korean Patients With 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

COMPLETED

Total Enrollment

924 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-12-03

Study Completion Date

2021-12-15

Brief Summary

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The purpose of the study is to evaluate the safety and effectiveness of Xarelto in renally impaired patients with NVAF under routine practice conditions. The information collected in the XARENAL study will help to understand how renally impared patients with NVAF are treated in the real-world setting and what the outcome for the patients is under those conditions.

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Detailed Description

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Conditions

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Non-valvular Atrial Fibrillation (NVAF)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Treatment

Patients will be followed according to routine medical practice and the frequency of visits and procedures will be performed under routine conditions.

Rivaroxaban(Xarelto,BAY 59-7939)

Intervention Type DRUG

10mg, 15mg and 20 mg film-coated tablets

Interventions

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Rivaroxaban(Xarelto,BAY 59-7939)

10mg, 15mg and 20 mg film-coated tablets

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Female and male patients ≥ 19 years of age
* Diagnosis of NVAF
* Patients for whom the decision to initiate treatment with rivaroxaban has already been made as per physician's routine treatment practice
* Previous documented creatinine clearance rate of 15-49mL/min within 6 months before enrollment
* Written informed consent of the patient

Exclusion Criteria

* Contraindications for rivaroxaban according to the current Korean market authorization and Summary of Product Characteristics (SmPC).
* Patients participating in an investigational program with interventions outside of routine clinical practice.
* Planned treatment with other anticoagulants.
* Expected renal-replacement therapy within the next 3 months

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No