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

Non-valvular Atrial Fibrillation (NVAF) Clinical Trial

— XARENAL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03746301
• Other study ID #: 20286
• Status: Completed
• Start date: December 3, 2018
• Est. completion date: December 15, 2021

Study information

• Verified date: December 2022
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 924
• Est. completion date: December 15, 2021
• Est. primary completion date: July 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Rivaroxaban(Xarelto,BAY 59-7939)
10mg, 15mg and 20 mg film-coated tablets

Locations

Country	Name	City	State
Korea, Republic of	Many locations	Multiple Locations

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Janssen Research & Development, LLC

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Occurrence of AEs and SAEs		Up to 12 months
Secondary	Occurrence of all-cause mortality		Up to 12 months
Secondary	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
Secondary	Incidence proportion of Symptomatic thromboembolic events	Symptomatic thromboembolic events collected as SAEs or non-serious AEs.	Up to 12 months
Secondary	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
Secondary	The change in creatinine clearance from baseline		At month 3,6,9 and 12

External Links

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