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N/A N=8

Can Rivaroxaban Lead to Anticoagulation-Related Nephropathy?

Acute Kidney Injury

Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Jun 2020
Primary outcome: Primary: Incidence of Anticoagulant-related Nephropathy in the Cohort — 0 Percentage of participants

Study Design & Population

Study type
Observational
Phase
N/A
Interventions
Age
Adult, Older Adult · 60+ yrs
Sex
All
Sponsor
Albert Einstein Healthcare Network
Primary completion
Jun 2018

Outcome Measures

OutcomeResultp-value
PRIMARY
Incidence of Anticoagulant-related Nephropathy in the Cohort

Summary

Anticoagulation-Related Nephropathy (ARN) is a side effect of treatment with blood thinners which leads to kidney dysfunction. A recent review suggests that kidney function should be assessed (by measuring serum creatinine) serially in the first few months of starting a blood thinner. ARN is diagnosed when there is a decline in kidney function after starting the blood thinner and other possible causes of this decline have been excluded. ARN has mainly been studied in relation to the common blood thinner - warfarin, where the prevalence is variable but can be as high as 37% (approximately 1 in 3) in the patients at highest risk. The risk factors that make this side effect more likely include the presence of pre-existing kidney disease, high blood pressure, older age and diabetes mellitus. Studies have shown that the occurence of ARN can lead to an accelerated progression of pre-existing kidney disease and a 65% increase in the risk of death (mortality). The non-vitamin K oral anticoagulants (NOACs) are a new group of drugs which have been recently approved for use as blood thinners. They have a faster onset of action compared to warfarin and unlike warfarin, they do not need frequent monitoring. Rivaroxaban is the most commonly prescribed NOAC at Einstein Medical Center Philadelphia. There are some case reports that other NOACs (such as dabigatran and apixaban) can lead to ARN, however there is no study that has determined the true incidence of ARN in NOACs. Our study is designed to find out the incidence of ARN in patients who are started on rivaroxaban. The investigators intend to serially monitor the kidney function of 40 high risk patients who are recently started on rivaroxaban over a six month period. This will enable us to discover how many patients actually develop ARN after starting a NOAC. The information the investigators will obtain from this study will enable patients and health care providers make better decisions about using blood thinners. If the investigators find that the incidence of ARN with rivaroxaban is less common than that previously reported with warfarin, it can potentially make more patients use the NOACs and hence save them from the morbidity and mortality associated with ARN. Our study is unique because this will be the first study focused on ARN in one of the new blood thinners. The information the investigators get from this study will be a very important foundation for future studies.

Eligibility Criteria

Inclusion Criteria

  • Age ≥ 60 years
  • GFR ≤ 60 ml/L based on creatinine clearance
  • Participant has been initiated on long term anticoagulation with rivaroxaban for atrial fibrillation within four weeks of recruitment

Exclusion Criteria

  • History of blood dyscrasias or active bleeding,
  • History of hematuria
  • Patients on dialysis
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02900170). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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