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

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

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.

Study Overview

• Status: Completed
• Conditions: Non-valvular Atrial Fibrillation (NVAF)
• Intervention / Treatment: Drug: Rivaroxaban(Xarelto,BAY 59-7939)

• Study Type: Observational
• Enrollment (Actual): 924

Contacts and Locations

Study Locations

• Korea, Republic of
  • Multiple Locations, Korea, Republic of
    • Many Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with NVAF who have moderate (creatinine clearance 30 - 49 ml/min) or severe (creatinine clearance 15 - 29 ml/min) renal impairment, requiring rivaroxaban for the prevention of stroke or non-CNS systemic embolism. Patients must also meet all the eligibility criteria for the study.

Description

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

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
Treatment; Patients will be followed according to routine medical practice and the frequency of visits and procedures will be performed under routine conditions.	Drug: Rivaroxaban(Xarelto,BAY 59-7939); 10mg, 15mg and 20 mg film-coated tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence proportion of major bleeding	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.	Up to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of AEs and SAEs		Up to 12 months
Occurrence of all-cause mortality		Up to 12 months
Occurrence of Non-major bleeding	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.	Up to 12 months
Incidence proportion of Symptomatic thromboembolic events	Symptomatic thromboembolic events collected as SAEs or non-serious AEs.	Up to 12 months
Days 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
The change in creatinine clearance from baseline		At month 3,6,9 and 12

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

• Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2018
• Primary Completion (Actual): July 28, 2021
• Study Completion (Actual): December 15, 2021

Study Registration Dates

• First Submitted: November 16, 2018
• First Submitted That Met QC Criteria: November 16, 2018
• First Posted (Actual): November 19, 2018

Study Record Updates

• Last Update Posted (Estimate): December 8, 2022
• Last Update Submitted That Met QC Criteria: December 6, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Non-valvular Atrial fibrillation (NVAF), Stroke; Non-Central Nervous Systemic (CNS) embolism
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Arrhythmias, Cardiac; Embolism; Atrial Fibrillation; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Rivaroxaban
• Other Study ID Numbers: 20286

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