Factor XA - Inhibition in RENal Patients With Non-valvular Atrial Fibrillation - Observational Registry

Study Overview
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Brief Summary
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The multicenter registry will collect clinical data from 1600 patients with non valvular atrial fibrillation (NVAF) and chronic kidney disease (eGFR 15-49 mL/min per 1.73 m2). The overall objective of this registry is to assess chronic kidney disease (CKD) progression and clinical outcomes with regard to anticoagulation strategies in NVAF patients with eGFR 15-49 mL/min per 1.73 m2 in routine clinical practice.

Detailed Description
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This is a prospective registry allowing a structured, non-interventional collection of data. Participating physicians will not be subject to any instructions with regard to the diagnosis and therapy of their patients. All patient treatment is carried out within clinical routine, at the discretion of the physician and according to existing treatment guidelines. This registry will be carried out as an investigator-initiated, multicentre, prospective, non-interventional and observational registry at approximately 160 sites in Germany, Austria, Switzerland, France, Belgium and Luxembourg. The registry will collect clinical data of approximately 1600 patients with CKD (eGFR 15-49 mL/min per 1.73 m2) and NVAF receiving rivaroxaban, OAC with VKA, or no AC therapy, who are prospectively followed for a flexible duration with a minimal follow-up duration of 12 months until study end is announced (planned minimum 360 days / planned maximum 84 months). The plan of the registry is to include at least 1600 patients with CKD and NVAF and rivaroxaban therapy or VKA therapy or no AC therapy. The aim is to include at least 700 patients with rivaroxaban therapy and VKA therapy, respectively. Into the exploratory treatment arm of patients receiving no AC therapy about 100 patients will be included.

Official Title
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Factor XA - Inhibition in RENal Patients With Non-valvular Atrial Fibrillation - Observational Registry

Conditions
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Non-valvular Atrial Fibrillation (NVAF), Chronic Kidney Disease (CKD)

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: male and female patients, age ≥ 18 years CKD with eGFR 15 - 49 mL/min per 1.73 m2 non-valvular atrial fibrillation (NVAF) with indication for anticoagulation therapy a treatment strategy for the ≥ 3 previous months before enrolment with either: rivaroxaban or VKA (OAC cohorts) or no anticoagulation (no AC cohort) informed consent availability for follow up life expectancy of ≥6 months Exclusion Criteria: exclusion criteria according to the local product information for the respective anticoagulation treatment planned treatment with other anticoagulants expected renal-replacement therapy within the next 3 months

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| VKA - Vitamin K antagonist group<br>VKAs used in correspondence with the national guidelines for therapy of NVAF in the respective country. | |
| Rivaroxaban group<br>Rivaroxaban used in correspondence with the national guidelines for therapy of NVAF in the respective country. | |
| noAC group<br>noAC used in correspondence with the national guidelines for therapy of NVAF in the respective country. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| decline in eGFR in mL/min per 1.73 m2 |  | 12 month | 
| major bleeding |  | 12 month | 
| all-cause mortality |  | 12 month | 
| TIA, stroke or systemic arterial embolism |  | 12 month | 
| major cardiovascular events (MACE) |  | 12 month | 
| symptomatic venous thromboembolic events |  | 12 month | 
| net-clinical benefit (stroke and other thromboembolic events, major bleeding, and all-cause mortality) |  | 12 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| initiation of chronic renal replacement therapy |  | 12 month | 
| eGFR < 15 mL/min per 1.73 m2 (CKD Stage 5 Dialysis and Non-Dialysis) |  | 12 month | 
| eGFR decline of ≥ 30% |  | 12 month | 
| doubling of serum creatine concentration |  | 12 month | 
| acute kidney injury (AKI) events defined as acute kidney injury associated with either hospitalization or emergency department visit, where AKI event is the lead diagnosis |  | 12 month, 18 month | 
| rates of hospitalizations |  | 12 month, 18 month | 
| length of hospitalizations |  | 12 month, 18 month | 
| causes of hospitalizations |  | 12 month, 18 month | 
| persistence with OAC therapy |  | 12 month, 18 month | 
| reasons for OAC therapy discontinuation | descriptive analysis of reasons for therapy discontinuation (verbal description by investigator) | 12 month, 18 month |