A Study Using Electronic Health Information to Learn About Rivaroxaban Compared to Warfarin in Participants With Non-valvular Atrial Fibrillation (NVAF) and Diabetes
- Conditions
- Atrial Fibrillation
- Interventions
- Registration Number
- NCT04509193
- Lead Sponsor
- Bayer
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 116049
- Be ≥18 years of age at the time of anticoagulation initiation
- Have diagnoses of type 2 diabetes and Non-valvular atrial fibrillation (NVAF)
- Have no record of prior oral anticoagulant (OAC) use in the prior 12-months
- Newly initiated on Rivaroxaban or Warfarin (index date)
- Have ≥12-months of electronic health record (EHR) activity prior to the index date and received care documented in the EHR database from at least one provider in the 12-months prior
- Evidence of valvular heart disease defined as any rheumatic heart disease, mitral stenosis or mitral valve repair/replacement
- Pregnancy
- Use of rivaroxaban doses other than 15 mg once daily or 20 mg once daily or the presence of other indication(s) for OAC use
- Any prior OAC utilization per written prescription or self-report at baseline
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Group A Rivaroxaban (Xarelto, BAY59-7939) Participants with diagnoses of type 2 diabetes and non-valvular atrial fibrillation (NVAF) newly-initiated on rivaroxaban Group B Warfarin Participants with diagnoses of type 2 diabetes and non-valvular atrial fibrillation (NVAF) newly-initiated on warfarin
- Primary Outcome Measures
Name Time Method Composite of stroke or systemic embolism Up to 8 years Any major or clinically-relevant nonmajor bleed resulting in hospitalization Up to 8 years
- Secondary Outcome Measures
Name Time Method Development of end-stage renal disease per billing codes only Up to 8 years Any extracranial bleeding Up to 8 years Development of serum potassium > 5.6 or >6 mg/dL Up to 8 years New-onset vascular dementia Up to 8 years Systemic embolism Up to 8 years Development of an eGFR<15 mL/min or initiation of dialysis Up to 8 years Glomerular filtration rate (GRF)
Ischemic stroke Up to 8 years Intracranial hemorrhage Up to 8 years Critical organ bleeding per ISTH categories Up to 8 years The categories for critical organ bleeding as per ISTH definition are: intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome.
Need for revascularization or major amputation of the lower limb 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 Up to 8 years Doubling of the serum creatinine level from baseline Up to 8 years Decrease in eGFR>30% or 40% Up to 8 years Glomerular filtration rate (GRF)
Development of urine albumin-to-creatinine ratio (UACR) of 30-300 or >300 Up to 8 years Development of diabetic retinopathy Up to 8 years Myocardial infarction Up to 8 years All-cause mortality Up to 8 years Vascular mortality Up to 8 years Major adverse cardiovascular event Up to 8 years Composite of stroke, systemic embolism, vascular death Up to 8 years Composite of stroke, systemic embolism, myocardial infarction, vascular death Up to 8 years Composite stroke, systemic embolism, need for lower limb revascularization or major amputation 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 Up to 8 years Glomerular filtration rate (GRF)
Trial Locations
- Locations (1)
US Optum De-Identified EHR data
🇺🇸Whippany, New Jersey, United States