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| Name | Class |
|---|---|
| Janssen Research & Development, LLC | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Patients will be followed according to routine medical practice and the frequency of visits and procedures will be performed under routine conditions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rivaroxaban(Xarelto,BAY 59-7939) | Drug | 10mg, 15mg and 20 mg film-coated tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| Up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of AEs and SAEs | Up to 12 months | |
| Occurrence of all-cause mortality | Up to 12 months | |
| Occurrence of Non-major bleeding |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with NVAF who have moderate (creatinine clearance 30 - 49 ml/min) or severe (creatinine clearance 15 - 29 ml/min) renal impairment, requiring rivaroxaban for the prevention of stroke or non-CNS systemic embolism. Patients must also meet all the eligibility criteria for the study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Many locations | Multiple Locations | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39601397 | Derived | Oh IY, Lee CH, Choi EK, Lim HE, Oh YS, Choi JI, Ahn MS, Kim JY, Kim NH, Yoon N, Sandmann M, Choi KJ. A Real-World, Prospective, Observational Study of Rivaroxaban on Prevention of Stroke and Non-Central Nervous Systemic Embolism in Renally Impaired Korean Patients With Non-Valvular Atrial Fibrillation: XARENAL. Korean Circ J. 2025 Feb;55(2):121-131. doi: 10.4070/kcj.2024.0154. Epub 2024 Oct 23. |
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Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.
Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
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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 |
| Incidence proportion of Symptomatic thromboembolic events | Symptomatic thromboembolic events collected as SAEs or non-serious AEs. | 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) | Up to 12 months |
| The change in creatinine clearance from baseline | At month 3,6,9 and 12 |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D004617 | Embolism |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016769 | Embolism and Thrombosis |
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