An observational study in Atrial Fibrillation, sponsored by Bayer. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-06-15.
Sponsored by Bayer · Observational
In people with type 2 diabetes, the body does not make enough of a hormone called insulin or does not use insulin well. This results in high blood sugar levels.
People with diabetes are more likely to have non-valvular atrial fibrillation (NVAF) compared to people who do not have diabetes. Having both NVAF and diabetes can increase the chances of developing other serious health conditions, like blood clots and strokes.
People with NVAF may receive treatments to help lower the risk of blood clots. This can then help to lower the risk of having a stroke. Two of these treatments are rivaroxaban and warfarin.
In this study, the researchers will look at how well rivaroxaban works and how safe it is compared to warfarin in routine clinical practice. The study will include men and women who are at least age 18 and who have NVAF and type 2 diabetes.
The researchers in this study will use the participants' health information from an electronic database.
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's enrollment of 116,049 is above the median of 300 across 1,363 observational studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.
Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.
Counted across the registry records on this site, refreshed daily.
The study is using Optum electronic health record (EHR) database. The study population of interest will be US participants with Non-valvular atrial fibrillation (NVAF) and comorbid type 2 diabetes, oral anticoagulation (OAC)-naïve and newly-initiated on rivaroxaban or warfarin, be active in the data set and have received care.
Exclusion Criteria:
Participants with diagnoses of type 2 diabetes and non-valvular atrial fibrillation (NVAF) newly-initiated on rivaroxaban
Drug: Rivaroxaban (Xarelto, BAY59-7939)
Participants with diagnoses of type 2 diabetes and non-valvular atrial fibrillation (NVAF) newly-initiated on warfarin
Drug: Warfarin
Participants receive rivaroxaban (per written prescription, medication administration or self-report of medication use)
Participants receive warfarin (per written prescription, medication administration or self-report of medication use)
Composite of stroke or systemic embolism
Time frame: Up to 8 years
Any major or clinically-relevant nonmajor bleed resulting in hospitalization
Time frame: Up to 8 years
Ischemic stroke
Time frame: Up to 8 years
Systemic embolism
Time frame: Up to 8 years
Need for revascularization or major amputation of the lower limb
Time frame: Up to 8 years
Intracranial hemorrhage
Time frame: Up to 8 years
Critical organ bleeding per ISTH categories
The categories for critical organ bleeding as per ISTH definition are: intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome.
Time frame: Up to 8 years
Any extracranial bleeding
Time frame: Up to 8 years
Any hospitalization due to intracranial or critical organ bleeding or a bleed in another location associated with either a 2 g/dL drop in hemoglobin or need for transfusion
Time frame: Up to 8 years
Doubling of the serum creatinine level from baseline
Time frame: Up to 8 years
Decrease in eGFR>30% or 40%
Glomerular filtration rate (GRF)
Time frame: Up to 8 years
Development of an eGFR<15 mL/min or initiation of dialysis
Glomerular filtration rate (GRF)
Time frame: Up to 8 years
Development of end-stage renal disease per billing codes only
Time frame: Up to 8 years
Development of urine albumin-to-creatinine ratio (UACR) of 30-300 or >300
Time frame: Up to 8 years
Development of serum potassium > 5.6 or >6 mg/dL
Time frame: Up to 8 years
Development of diabetic retinopathy
Time frame: Up to 8 years
Myocardial infarction
Time frame: Up to 8 years
All-cause mortality
Time frame: Up to 8 years
Vascular mortality
Time frame: Up to 8 years
Major adverse cardiovascular event
Time frame: Up to 8 years
Composite of stroke, systemic embolism, vascular death
Time frame: Up to 8 years
Composite of stroke, systemic embolism, myocardial infarction, vascular death
Time frame: Up to 8 years
Composite stroke, systemic embolism, need for lower limb revascularization or major amputation
Time frame: Up to 8 years
Composite of >40% decrease in eGFR from baseline, eGFR<15 mL/minute, need for dialysis, renal transplant, major adverse limb event, retinopathy or all-cause death
Glomerular filtration rate (GRF)
Time frame: Up to 8 years
New-onset vascular dementia
Time frame: Up to 8 years
Plan to share: No — 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.
This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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