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

Bayer924 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

924

Conditions

Non-valvular Atrial Fibrillation (NVAF)

Interventions

Rivaroxaban(Xarelto,BAY 59-7939)DRUG

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

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Locations (1)

Many locations

Multiple Locations, South Korea

Outcomes

Primary Outcomes

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.

Time frame: Up to 12 months

Secondary Outcomes

Occurrence of AEs and SAEs

Time frame: Up to 12 months

Occurrence of all-cause mortality

Time frame: 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.

Time frame: Up to 12 months

Incidence proportion of Symptomatic thromboembolic events

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

Time frame: 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)

Time frame: Up to 12 months

The change in creatinine clearance from baseline

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

Data from ClinicalTrials.gov

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