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NCT02900170 · ClinicalTrials.gov registry record
Can Rivaroxaban Lead to Anticoagulation-Related Nephropathy?
A clinical trial, sponsored by Albert Einstein Healthcare Network.
- Completed
- Registry status
- 8
- Enrollment target
NCT02900170: Completed study, sponsored by Albert Einstein Healthcare Network.
NCT02900170 is a clinical trial that has completed, run by Albert Einstein Healthcare Network. The registered enrollment target is 8 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02900170 has completed, sponsored by Albert Einstein Healthcare Network.
- COMPLETED
- Registry status
- 8 participants
- Enrollment target
Study 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 in
Primary Outcome
Primary endpoint - Incidence of ARN is the primary outcome of this study and this is based on a documentation of AKI (defined as an increase in baseline serum creatinine ≥ 0.3 mg/dL), in the absence of any other obvious etiology for the AKI identified after a standard clinical evaluation and work up by the patient's primary care physician, cardiologist or nephrologist. This incidence will be expressed as a percentage.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2016-07 |
| Est. Completion | 2018-06-11 |
What the finished NCT02900170 record still lists
NCT02900170 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 8 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT02900170 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02900170 about?
NCT02900170 is a clinical study titled "Can Rivaroxaban Lead to Anticoagulation-Related Nephropathy?". 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 diagnos...
What is the current status of trial NCT02900170?
This trial is currently completed. The enrollment target is 8 participants. The study started on 2016-07. Estimated completion is 2018-06-11.
Who is sponsoring clinical trial NCT02900170?
This trial is sponsored by Albert Einstein Healthcare Network, which has 48 total clinical trials registered on ClinicalTrials.gov.
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