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| Name | Class |
|---|---|
| Janssen Research & Development, LLC | INDUSTRY |
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By evaluating routine clinical practice data from the UK primary care database, researchers in this study want to gather information on the kidney function of patients with non-valvular atrial fibrillation (NVAF, irregularly heart beats which is not caused by a heart valve problem) who are treated with Rivaroxaban (non-vitamin K antagonist, brand name Xarelto) or vitamin K antagonists (VKAs). The study planned to enroll about 25,000 male or female patients who were at least 18 years old and were new users of Rivaroxaban or VKAs between 01 January 2014 and 30 September 2019. Researchers are especially interested in whether patients experienced under treatment any worsening in kidney function, the onset of acute kidney diseases or injuries. In addition, risk of worsening in kidney function in patients with or without diabetes or heart failures are of interest to the researchers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rivaroxaban | Participants in this group administered oral anticoagulant Rivaroxaban |
| |
| Vitamin-K antagonists (VKAs) | Participants in this group administered oral anticoagulants VKAs |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rivaroxaban (Xarelto, BAY-597939) | Drug | Non-vitamin K antagonist oral anticoagulants (NOACs). The prescription of drug is at the discretion of physician following the routine clinical practice. |
| Measure | Description | Time Frame |
|---|---|---|
| A 20%, 30%, 40%, or 50% increase in serum creatinine (SCr) at any point of time during follow-up (confirmed by a subsequent measurement) | Retrospectively analysis from 01 January 2014 to 30 September 2019 | |
| Doubling of SCr from initiation (start date) at any point of time during follow-up | Retrospectively analysis from 01 January 2014 to 30 September 2019 | |
| Rate of change in eGFR from initiation (start date) | To be included in the estimated glomerular filtration rates (eGFR) slope analyses at least two post-baseline assessments were required, where the first measurement was less than 120 days after index and the last was more than 180 days after the first post-baseline (reflecting sufficient time for a potential change to occur) | Retrospectively analysis from 01 January 2014 to 30 September 2019 |
| A 20%, 30%, 40%, or 50% decline of eGFR at any point of time during follow-up (confirmed by a subsequent measurement) | Retrospectively analysis from 01 January 2014 to 30 September 2019 | |
| Incidence of end-stage renal disease | Retrospectively analysis from 01 January 2014 to 30 September 2019 | |
| Incidence of acute kidney injury | Retrospectively analysis from 01 January 2014 to 30 September 2019 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients aged ≥18 years with NVAF and no record of ESRD, with a first prescription for rivaroxaban or a VKA and no previous OAC use between 01 January 2014 and 30 September 2019
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Many locations | Multiple Locations | United Kingdom |
Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
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| VKAs | Drug | Oral anticoagulant. The prescription of drug is at the discretion of physician following the routine clinical practice. |
|
| ID | Term |
|---|---|
| D000069552 | Rivaroxaban |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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