Clinical trial NCT04509193: A Study Using Electronic Health Information to Learn About Rivaroxaban Compared to Warfarin in Participants With Non-valvular Atrial Fibrillation (NVAF) and Diabetes
Official title: RIVA-DM: Effectiveness and Safety of Rivaroxaban vs. Warfarin in Nonvalvular Atrial Fibrillation and Diabetes Mellitus: Analysis of Electronic Health Record Data
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Janssen Research & Development, LLC
First posted: 2020-08-11
Enrollment: 116049
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Composite of stroke or systemic embolism
timeFrame: Up to 8 years
measure: Any major or clinically-relevant nonmajor bleed resulting in hospitalization
timeFrame: Up to 8 years
Secondary outcomes:
measure: Ischemic stroke
timeFrame: Up to 8 years
measure: Systemic embolism
timeFrame: Up to 8 years
measure: Need for revascularization or major amputation of the lower limb
timeFrame: Up to 8 years
measure: Intracranial hemorrhage
timeFrame: Up to 8 years
measure: Critical organ bleeding per ISTH categories
timeFrame: Up to 8 years
measure: Any extracranial bleeding
timeFrame: Up to 8 years
measure: 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
timeFrame: Up to 8 years
measure: Doubling of the serum creatinine level from baseline
timeFrame: Up to 8 years
measure: Decrease in eGFR>30% or 40%
timeFrame: Up to 8 years
measure: Development of an eGFR<15 mL/min or initiation of dialysis
timeFrame: Up to 8 years
measure: Development of end-stage renal disease per billing codes only
timeFrame: Up to 8 years
measure: Development of urine albumin-to-creatinine ratio (UACR) of 30-300 or >300
timeFrame: Up to 8 years
measure: Development of serum potassium > 5.6 or >6 mg/dL
timeFrame: Up to 8 years
measure: Development of diabetic retinopathy
timeFrame: Up to 8 years
measure: Myocardial infarction
timeFrame: Up to 8 years
measure: All-cause mortality
timeFrame: Up to 8 years
measure: Vascular mortality
timeFrame: Up to 8 years
measure: Major adverse cardiovascular event
timeFrame: Up to 8 years
measure: Composite of stroke, systemic embolism, vascular death
timeFrame: Up to 8 years
measure: Composite of stroke, systemic embolism, myocardial infarction, vascular death
timeFrame: Up to 8 years
measure: Composite stroke, systemic embolism, need for lower limb revascularization or major amputation
timeFrame: Up to 8 years
measure: 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
timeFrame: Up to 8 years
measure: New-onset vascular dementia
timeFrame: Up to 8 years
Other outcomes:
Locations:
city: Whippany
country: United States
facility: US Optum De-Identified EHR data
state: New Jersey
Study officials:
References:
citation: Costa OS, O'Donnell B, Vardar B, Abdelgawwad K, Brescia CW, Sood N, Coleman CI. Kidney, limb and ophthalmic complications, and death in patients with nonvalvular atrial fibrillation and type 2 diabetes prescribed rivaroxaban or warfarin: an electronic health record analysis. Curr Med Res Opin. 2021 Sep;37(9):1493-1500. doi: 10.1080/03007995.2021.1947217. Epub 2021 Jul 8.