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

Completed

• Conditions: Non-valvular Atrial Fibrillation (NVAF)
• Interventions: Drug: Rivaroxaban(Xarelto,BAY 59-7939)

• Registration Number: NCT03746301
• Lead Sponsor: Bayer

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2018-11-16
• Study First Submitted QC: 2018-11-16
• Study First Posted: 2018-11-19
• Study Start: 2018-12-03
• Primary Completion: 2021-07-28
• Study Completion: 2021-12-15
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-06
• Last Update Posted: 2022-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 924

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

Read More

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Treatment	Rivaroxaban(Xarelto,BAY 59-7939)	Patients will be followed according to routine medical practice and the frequency of visits and procedures will be performed under routine conditions.

Primary Outcome Measures

Name	Time	Method
Incidence proportion of major bleeding	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 Outcome Measures

Name	Time	Method
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	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.
Incidence proportion of Symptomatic thromboembolic events	Up to 12 months	Symptomatic thromboembolic events collected as SAEs or non-serious AEs.
Days of rivaroxaban treatment	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)
The change in creatinine clearance from baseline	At month 3,6,9 and 12

Trial Locations

Locations (1)

Many locations; 🇰🇷 Multiple Locations, Korea, Republic of