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

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Multicentre, prospective, and observational registry

Study drug and medical condition

• Medical condition to be studied:
  Chronic kidney disease
• Additional medical condition(s):
  Non-valvular Atrial Fibrillation (NVAF)

Population studied

• Short description of the study population:
  Patients with non-valvular atrial fibrillation (NVAF) and chronic kidney disease (CKD) aged 18 years or older received treatment with rivaroxaban therapy or VKA therapy or no anticoagulation therapy.; Inclusion criteria:; - Male and female patients, age ≥ 18 years; - CKD with eGFR 15 – 49 mL/min per 1.73 m2; - Documented NVAF with indication for anticoagulation therapy; - A treatment strategy for the ≥ 3 previous months before enrolment with either:; ▪ rivaroxaban or; ▪ VKA (oral anticoagulation [OAC] cohorts) or; ▪ no anticoagulation (no AC cohort) received (if applicable) at the earliest in January 2012; - 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 chronic treatment with other anticoagulants; - Expected renal replacement therapy within the next 3 months
• Age groups:
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Patients with atrial fibrillation and chronic kidney disease
• Estimated number of subjects:
  1600

Study design details

• Main study objective:
  The multicentre registry will collect clinical data from 2500 patients with NVAF and chronic kidney disease (CKD) with an estimated glomerular filtration rate (eGFR) (15-49 mL/min per 1.73 m2). The overall objective of this registry is to assess CKD progression and safety of anticoagulation strategies in NVAF patients with eGFR 15-49 mL/min per 1.73 m2 in routine clinical practice.
• Outcomes:
  - decline in eGFR in mL/min per 1.73 m2 - major bleeding - all-cause mortality - TIA, stroke or systemic arterial embolism - major cardiovascular events (MACE) - Myocardial infarction - Acute coronary syndrome/unstable angina - symptomatic venous thromboembolic events - net-clinical benefit (stroke and other thromboembolic events, major bleeding, and all-cause mortality), - initiation of chronic renal replacement therapy - eGFR < 15 mL/min per 1.73 m2 (CKD Stage 5 Dialysis and Non-Dialysis) - eGFR decline of ? 30% - doubling of serum creatine concentration - acute kidney injury (AKI) events - rates, causes and length of hospitalizations - persistence with OAC therapy - reasons for OAC therapy discontinuation
• Data analysis plan:
  Statistical analyses will be descriptive and exploratory only. For continuous parameters summary statistics will be presented. For categorical variables absolute and relative frequencies will be presented. All tables will be generated by treatment (Rivaroxaban, VKA or no AC) and total. To get an idea if potentially observed differences in treatment could be of relevance, 95 % confidence intervals of the treatment differences between Rivaroxaban and VKA will be calculated.