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

NCT03746301 | Completed

• 1 other identifier: 20286
• Study Type: observational
• Target: 924
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Non-valvular Atrial Fibrillation (NVAF)

Keywords

Non-valvular Atrial fibrillation (NVAF), Stroke; Non-Central Nervous Systemic (CNS) embolism

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Occurrence of AEs and SAEs

  Up to 12 months

• Occurrence of all-cause mortality

  Up to 12 months

• Occurrence of Non-major bleeding

  Up to 12 months

• Incidence proportion of Symptomatic thromboembolic events

  Up to 12 months

• Days of rivaroxaban treatment

  Up to 12 months

Study Arms (1)

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)

Interventions

Rivaroxaban(Xarelto,BAY 59-7939) DRUG

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

Treatment

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead
• Janssen Research & Development, LLC: collaborator

Study Sites (1)

Many locations

Multiple Locations, South Korea

Location

Related Publications (1)

• Oh IY, Lee CH, Choi EK, Lim HE, Oh YS, Choi JI, Ahn MS, Kim JY, Kim NH, Yoon N, Sandmann M, Choi KJ. A Real-World, Prospective, Observational Study of Rivaroxaban on Prevention of Stroke and Non-Central Nervous Systemic Embolism in Renally Impaired Korean Patients With Non-Valvular Atrial Fibrillation: XARENAL. Korean Circ J. 2025 Feb;55(2):121-131. doi: 10.4070/kcj.2024.0154. Epub 2024 Oct 23.

  PMID: 39601397 DERIVED

Related 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.

MeSH Terms

Conditions

Stroke; Embolism

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Embolism and Thrombosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2018
• First Posted: November 19, 2018
• Study Start: December 3, 2018
• Primary Completion: July 28, 2021
• Study Completion: December 15, 2021
• Last Updated: December 8, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)