Non-valvular Atrial Fibrillation (NVAF)
Conditions
Keywords
Non-valvular Atrial fibrillation (NVAF), Stroke; Non-Central Nervous Systemic (CNS) embolism
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.
Interventions
DRUGRivaroxaban(Xarelto,BAY 59-7939)
10mg, 15mg and 20 mg film-coated tablets
Sponsors
Janssen Research & Development, LLC
Bayer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Occurrence of AEs and SAEs | Up to 12 months | — |
| 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 | — |
| Incidence proportion of Symptomatic thromboembolic events | Up to 12 months | Symptomatic thromboembolic events collected as SAEs or non-serious AEs. |
Countries
South Korea
Outcome results
None listed