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

Non-valvular Atrial Fibrillation (NVAF) Clinical Trial

— XARETO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04356989
• Other study ID #: 20901
• Status: Completed
• Start date: May 13, 2020
• Est. completion date: January 16, 2023

Study information

• Verified date: December 2023
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 493
• Est. completion date: January 16, 2023
• Est. primary completion date: November 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Non-valvular Atrial Fibrillation (NVAF)

Intervention

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.

Locations

Country	Name	City	State
Taiwan	Many Locations	Multiple Locations

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Janssen Research & Development, LLC

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major bleeding events		Up to 12 months
Secondary	Occurrence of adverse events (AEs) and serious adverse events (SAEs)		Up to 12 months
Secondary	Occurrence of All-cause mortality		Up to 12 months
Secondary	Occurrence of non-major bleeding events		Up to 12 months
Secondary	Occurrence of symptomatic thromboembolic events		Up to 12 months
Secondary	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
Secondary	Changes in creatinine clearance (CrCl) from baseline		Up to 12 months

External Links

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