check_circleStudy Completed
Non-valvular atrial fibrillation (NVAF)
Bayer Identifier:
21615
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
A study to learn whether there are differences in the kidney’s ability to work properly in Korean patients with non-valvular atrial fibrillation (irregular and often rapid heartbeat not caused by a heart valve problem) treated with rivaroxaban as compared to those treated with warfarin
Trial purpose
This is an observational study in which data collected from the past of patients with non-valvular atrial fibrillation (NVAF) is studied.
NVAF is a condition in which patients suffer from irregular and often rapid heartbeats which are not caused by a heart valve problem. NVAF can lead to thromboembolism, a condition that happens when a blood clot forms in the body and travels through the blood stream to plug another vessel. To prevent thromboembolism doctors often prescribe a blood thinner medication.
In patients with NVAF that receive a blood thinner, it is common that the kidneys’ ability to work properly, also called the kidney function, decreases. This may increase the risk of stroke, a condition which occurs when a vessel supplying blood to the brain is blocked and the risk of bleeding. It is therefore important to maintain the kidneys’ ability to work properly in these patients who are treated with blood thinners.
In the beginning, only one blood thinner that could be given as a tablet by mouth was available. This blood thinner was called warfarin. Over the years, further medications have become available, for example dabigatran or rivaroxaban. There is some evidence that a decrease of the kidney function is more common with warfarin than with dabigatran or rivaroxaban. For other similar new treatments however, evidence is missing or conflicting. There also could be other relevant factors such as the kidney function before the start of treatment or the patient’s genes/origin.
In this study researchers want to collect more data to compare two different blood thinner medications, rivaroxaban and warfarin. The main goal is to see whether there is a difference between the two treatments regarding the kidneys’ ability to work properly. To find this out, the researchers will compare the number of patients in each group who developed chronic kidney disease stage 5 (close to or corresponding to chronic kidney failure), had a kidney transplant or needed to undergo long term dialysis. In addition, data is collected and compared about the patients’ age, gender, weight, height and whether they had other related medical problems.
This study will collect information from the health records from the Korean National Health Insurance Corporation (NHIC) database. Besides this data collection, no further tests or examinations are planned in this study. Researchers will look at the health information from adult men and women in Korea who were diagnosed with NVAF between January 2013 and December 2017. They will study data of the patients who did not receive any medication with blood thinners in past 24 months before starting rivaroxaban and warfarin treatment between January 2015 and December 2017. They will follow up all the participants until December 2018.
NVAF is a condition in which patients suffer from irregular and often rapid heartbeats which are not caused by a heart valve problem. NVAF can lead to thromboembolism, a condition that happens when a blood clot forms in the body and travels through the blood stream to plug another vessel. To prevent thromboembolism doctors often prescribe a blood thinner medication.
In patients with NVAF that receive a blood thinner, it is common that the kidneys’ ability to work properly, also called the kidney function, decreases. This may increase the risk of stroke, a condition which occurs when a vessel supplying blood to the brain is blocked and the risk of bleeding. It is therefore important to maintain the kidneys’ ability to work properly in these patients who are treated with blood thinners.
In the beginning, only one blood thinner that could be given as a tablet by mouth was available. This blood thinner was called warfarin. Over the years, further medications have become available, for example dabigatran or rivaroxaban. There is some evidence that a decrease of the kidney function is more common with warfarin than with dabigatran or rivaroxaban. For other similar new treatments however, evidence is missing or conflicting. There also could be other relevant factors such as the kidney function before the start of treatment or the patient’s genes/origin.
In this study researchers want to collect more data to compare two different blood thinner medications, rivaroxaban and warfarin. The main goal is to see whether there is a difference between the two treatments regarding the kidneys’ ability to work properly. To find this out, the researchers will compare the number of patients in each group who developed chronic kidney disease stage 5 (close to or corresponding to chronic kidney failure), had a kidney transplant or needed to undergo long term dialysis. In addition, data is collected and compared about the patients’ age, gender, weight, height and whether they had other related medical problems.
This study will collect information from the health records from the Korean National Health Insurance Corporation (NHIC) database. Besides this data collection, no further tests or examinations are planned in this study. Researchers will look at the health information from adult men and women in Korea who were diagnosed with NVAF between January 2013 and December 2017. They will study data of the patients who did not receive any medication with blood thinners in past 24 months before starting rivaroxaban and warfarin treatment between January 2015 and December 2017. They will follow up all the participants until December 2018.
Key Participants Requirements
Sex
AllAge
20 - N/ATrial summary
Enrollment Goal
45000Trial Dates
October 2021 - October 2022Phase
Phase 4Could I Receive a placebo
NoProducts
Xarelto (Rivaroxaban, BAY59-7939)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Many locations | Many locations, KOREA, REPUBLIC OF |
Primary Outcome
- Incidence of kidney failureKidney failure is defined as progression to stage 5 chronic kidney disease (CKD), the need for maintenance dialysis, or having a kidney transplantdate_rangeTime Frame:Retrospective analysis from 01-Jan-2015 to 31-Dec-2018
Secondary Outcome
- Number of participants with ≥ 30% decline in estimated glomerular filtration rate (eGFR)date_rangeTime Frame:Retrospective analysis from 01-Jan-2015 to 31-Dec-2018
- Number of participants with doubling of the serum creatinine leveldate_rangeTime Frame:Retrospective analysis from 01-Jan-2015 to 31-Dec-2018
- Incidence of Acute kidney injury (AKI)AKI is defined as an emergency department visit or hospitalization with a diagnostic code of AKIdate_rangeTime Frame:Retrospective analysis from 01-Jan-2015 to 31-Dec-2018
- Number of participants with composite renal outcome of ≥ 30% decline in eGFR, doubling of the serum creatinine level and kidney failuredate_rangeTime Frame:Retrospective analysis from 01-Jan-2015 to 31-Dec-2018
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A