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

Atrial Fibrillation Clinical Trial

— RIVA-DM  

Official title:

RIVA-DM: Effectiveness and Safety of Rivaroxaban vs. Warfarin in Nonvalvular Atrial Fibrillation and Diabetes Mellitus: Analysis of Electronic Health Record Data

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04509193
• Other study ID #: 21449
• Secondary ID: EUPAS36634
• Status: Completed
• Start date: August 21, 2020
• Est. completion date: July 31, 2021

Study information

• Verified date: June 2022
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116049
• Est. completion date: July 31, 2021
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• Rivaroxaban (Xarelto, BAY59-7939)
Participants receive rivaroxaban (per written prescription, medication administration or self-report of medication use)
• Warfarin
Participants receive warfarin (per written prescription, medication administration or self-report of medication use)

Locations

Country	Name	City	State
United States	US Optum De-Identified EHR data	Whippany	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Janssen Research & Development, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite of stroke or systemic embolism		Up to 8 years
Primary	Any major or clinically-relevant nonmajor bleed resulting in hospitalization		Up to 8 years
Secondary	Ischemic stroke		Up to 8 years
Secondary	Systemic embolism		Up to 8 years
Secondary	Need for revascularization or major amputation of the lower limb		Up to 8 years
Secondary	Intracranial hemorrhage		Up to 8 years
Secondary	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.	Up to 8 years
Secondary	Any extracranial bleeding		Up to 8 years
Secondary	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
Secondary	Doubling of the serum creatinine level from baseline		Up to 8 years
Secondary	Decrease in eGFR>30% or 40%	Glomerular filtration rate (GRF)	Up to 8 years
Secondary	Development of an eGFR<15 mL/min or initiation of dialysis	Glomerular filtration rate (GRF)	Up to 8 years
Secondary	Development of end-stage renal disease per billing codes only		Up to 8 years
Secondary	Development of urine albumin-to-creatinine ratio (UACR) of 30-300 or >300		Up to 8 years
Secondary	Development of serum potassium > 5.6 or >6 mg/dL		Up to 8 years
Secondary	Development of diabetic retinopathy		Up to 8 years
Secondary	Myocardial infarction		Up to 8 years
Secondary	All-cause mortality		Up to 8 years
Secondary	Vascular mortality		Up to 8 years
Secondary	Major adverse cardiovascular event		Up to 8 years
Secondary	Composite of stroke, systemic embolism, vascular death		Up to 8 years
Secondary	Composite of stroke, systemic embolism, myocardial infarction, vascular death		Up to 8 years
Secondary	Composite stroke, systemic embolism, need for lower limb revascularization or major amputation		Up to 8 years
Secondary	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)	Up to 8 years
Secondary	New-onset vascular dementia		Up to 8 years

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