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Completed

NCT Number: NCT03746301

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

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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Key information

Conditions

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

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many locations

Multiple Locations, South Korea

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Rivaroxaban(Xarelto,BAY 59-7939)

Drug

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

Primary outcomes

  1. Incidence proportion of major bleeding

    Time frame: Up to 12 months

    Incidence proportion of major bleeding events collects as serious or non-serious AEs and defined as overt bleeding associated with:

    • a fall in haemoglobin of ≥2 g/dL, or
    • a transfusion of ≥2 units of packed red blood cells or whole blood, or
    • occurrence at a critical site (intracranial, intra-spinal, intraocular, pericardial, intra articular, intra muscular with compartment syndrome, retroperitoneal), or
    • death.

Secondary outcomes

  1. Occurrence of AEs and 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

    Time frame: Up to 12 months

    Non-major bleeding events collected as SAEs or non-serious AEs and defined as all bleeding events that do not fall in the category of major bleeding.

  4. Incidence proportion of Symptomatic thromboembolic events

    Time frame: Up to 12 months

    Symptomatic thromboembolic events collected as SAEs or non-serious AEs.

  5. Days of rivaroxaban treatment

    Time frame: Up to 12 months

    Start of rivaroxaban therapy and, if applicable, stop of rivaroxaban therapy(in case of treatment discontinuation, switch, or interruption, the reason will be recorded)

  6. The change in creatinine clearance from baseline

    Time frame: At month 3,6,9 and 12

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

  • Janssen Research & Development, LLC

Registry information

Official study title

Xarelto® on Prevention of Stroke and Non-Central Nervous Systemic (CNS) Embolism in Renally Impaired Korean Patients With Non-valvular Atrial Fibrillation (NVAF)

Acronym: XARENAL

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Nov 19, 2018
Registry last updated
Dec 8, 2022

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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