A Study Using Electronic Health Information to Learn About Rivaroxaban Compared to Warfarin in Participants With Non-valvular Atrial Fibrillation (NVAF) and Diabetes

Bayer116,049 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

116,049

Conditions

Atrial Fibrillation

Interventions

Rivaroxaban (Xarelto, BAY59-7939)DRUG

Participants receive rivaroxaban (per written prescription, medication administration or self-report of medication use)

WarfarinDRUG

Participants receive warfarin (per written prescription, medication administration or self-report of medication use)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Locations (1)

US Optum De-Identified EHR data

Whippany, New Jersey, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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