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Study to Gain Information on the Drug Xarelto for the Prevention of Brain Attack and Blockage of an Artery in the Non-central Nervous System Due to Irregular Heartbeat in Taiwanese Patients Suffering From Decreased Renal Function

NCT ID: NCT04356989

Last Updated: 2023-12-28

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

493 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-13

Study Completion Date

2023-01-16

Brief Summary

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In this study researchers want to learn more about on the safety of the drug Xarelto. The study will enroll patients for whom the treating doctor are prescribing Xarelto for the prevention of brain attack or the prevention of blockage of an artery in the non-central nervous system. Only patients suffering from decreased renal function and irregular heart beat will be considered. The study plans to include 500 Taiwanese adult male and female patients with the age above 20 years. Patients will be followed up based on routine medical practice over a period of 12 months and information on their well-being and any medical events will collected.

Detailed Description

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Conditions

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Non-valvular Atrial Fibrillation (NVAF)

Keywords

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Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Rivaroxaban

Adult NVAF patients with renal impairment, who are prescribed with rivaroxaban to prevent stroke or non-central nervous system (CNS) systemic embolism (SE).

Rivaroxaban (Xarelto, BAY59-7939)

Intervention Type DRUG

The adminstration dose is decided by the attending physician in advance based on the patients' CrCl and in compliance with local market authorization of rivaroxaban.

Interventions

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Rivaroxaban (Xarelto, BAY59-7939)

The adminstration dose is decided by the attending physician in advance based on the patients' CrCl and in compliance with local market authorization of rivaroxaban.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Female and male patients ≥ 20 years of age
* Diagnosis of non-valvular atrial fibrillation (NVAF)
* Patients for whom the decision to initiate treatment with rivaroxaban is made as per physician's routine treatment practice
* Previously documented CrCl of 15-50 mL/min within 6 months before enrollment (last available value)

Exclusion Criteria

* Contraindications for rivaroxaban according to the local market authorization/ Summary of Product Characteristics
* 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

20 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

Locations

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Many Locations

Multiple Locations, , Taiwan

Site Status

Countries

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Taiwan

Related Links

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https://clinicaltrials.bayer.com/

Click here for access to information about Bayer's transparency standards and Bayer studies.

Other Identifiers

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20901

Identifier Type: -

Identifier Source: org_study_id