Many locations
Multiple Locations, South Korea
NCT Number: NCT05022758
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.
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Notify Me20 year and older
All sexes
Observational
Multiple Locations, South Korea
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
One of NOAC (Non-vitamin K antagonist oral anticoagulants)
One of OAC (Oral anticoagulation therapy)
Time frame: Retrospective analysis from 01-Jan-2015 to 31-Dec-2018
Kidney failure is defined as progression to stage 5 chronic kidney disease (CKD), the need for maintenance dialysis, or having a kidney transplant
Time frame: Retrospective analysis from 01-Jan-2015 to 31-Dec-2018
Time frame: Retrospective analysis from 01-Jan-2015 to 31-Dec-2018
Time frame: Retrospective analysis from 01-Jan-2015 to 31-Dec-2018
AKI is defined as an emergency department visit or hospitalization with a diagnostic code of AKI
Time frame: Retrospective analysis from 01-Jan-2015 to 31-Dec-2018
Bayer
Industry
RENal Outcomes of Rivaroxaban Compared With Warfarin in Asian patienTs With nOn-valvular atRial Fibrillation: a Nationwide Population-based Study
Acronym: RENOVATOR
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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