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 (XARETO)

Xarelto® for the Prevention of Stroke and Noncentral Nervous Systemic Embolism in Non-valvular Atrial Fibrillation With REnal Impairment in Taiwanese Population.

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.

Study Overview

• Status: Completed
• Conditions: Non-valvular Atrial Fibrillation (NVAF)
• Intervention / Treatment: Drug: Rivaroxaban (Xarelto, BAY59-7939)

• Study Type: Observational
• Enrollment (Actual): 493

Contacts and Locations

Study Locations

• Taiwan
  • Multiple Locations, Taiwan
    • Many Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population is composed of Taiwanese NVAF patients with documented CrCl of 15-50 mL/min, requiring rivaroxaban for the prevention of stroke or non-central nervous system (CNS) systemic embolism (SE). Patients must also meet all the eligibility for the study.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Rivaroxaban; Adult NVAF patients with renal impairment, who are prescribed with rivaroxaban to prevent stroke or non-central nervous system (CNS) systemic embolism (SE).	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Major bleeding events	Up to 12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Occurrence of adverse events (AEs) and serious adverse events (SAEs)	Up to 12 months
Occurrence of All-cause mortality	Up to 12 months
Occurrence of non-major bleeding events	Up to 12 months
Occurrence of symptomatic thromboembolic events	Up to 12 months
Day(s) of rivaroxaban treatment: start of rivaroxaban therapy and, if applicable, stop of rivaroxaban therapy (in case of treatment discontinuation, switch, or interruption, the reason will be recorded)	Up to 12 months
Changes in creatinine clearance (CrCl) from baseline	Up to 12 months

Collaborators and Investigators

• Sponsor: Bayer
• Collaborators: Janssen Research & Development, LLC

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2020
• Primary Completion (Actual): November 15, 2022
• Study Completion (Actual): January 16, 2023

Study Registration Dates

• First Submitted: April 21, 2020
• First Submitted That Met QC Criteria: April 21, 2020
• First Posted (Actual): April 22, 2020

Study Record Updates

• Last Update Posted (Actual): December 28, 2023
• Last Update Submitted That Met QC Criteria: December 21, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Stroke
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Rivaroxaban
• Other Study ID Numbers: 20901

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No