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Completed

NCT Number: NCT04356989

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

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.

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Key information

Conditions

Non-valvular Atrial Fibrillation (NVAF) Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations

Multiple Locations, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rivaroxaban (Xarelto, BAY59-7939)

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.

Primary outcomes

  1. Major bleeding events

    Time frame: Up to 12 months

Secondary outcomes

  1. Occurrence of adverse events (AEs) and serious adverse events (SAEs)

    Time frame: Up to 12 months

  2. Occurrence of All-cause mortality

    Time frame: Up to 12 months

  3. Occurrence of non-major bleeding events

    Time frame: Up to 12 months

  4. Occurrence of symptomatic thromboembolic events

    Time frame: Up to 12 months

  5. 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)

    Time frame: Up to 12 months

  6. Changes in creatinine clearance (CrCl) from baseline

    Time frame: Up to 12 months

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

  • Janssen Research & Development, LLC

Registry information

Official study title

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

Acronym: XARETO

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Apr 22, 2020
Registry last updated
Dec 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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