XARENAL: Xarelto on Prevention of Stroke and Non-Central Nervous Systemic Embolism in Renally Impaired Korean Patients With Non-valvular Atrial Fibrillation
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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)
10mg, 15mg and 20 mg film-coated tablets
|
Outcome Measures
Primary Outcome Measures
- 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
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Female and male patients ≥ 19 years of age
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Diagnosis of NVAF
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Patients for whom the decision to initiate treatment with rivaroxaban has already been made as per physician's routine treatment practice
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Previous documented creatinine clearance rate of 15-49mL/min within 6 months before enrollment
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Written informed consent of the patient
Exclusion Criteria:
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Contraindications for rivaroxaban according to the current Korean market authorization and Summary of Product Characteristics (SmPC).
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Patients participating in an investigational program with interventions outside of routine clinical practice.
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Planned treatment with other anticoagulants.
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Expected renal-replacement therapy within the next 3 months
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Many locations | Multiple Locations | Korea, Republic of |
Sponsors and Collaborators
- Bayer
- Janssen Research & Development, LLC
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 20286