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

Bayer

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Drug: Warfarin; Drug: Rivaroxaban (Xarelto, BAY59-7939)

Study type: Observational

Funder types: Industry

Identifiers

NCT04509193

EUPAS36634 (Other Identifier)

21449

Details and patient eligibility

About

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.

Enrollment: 116,049 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

116,049 participants in 2 patient groups

Group A

Description:

Participants with diagnoses of type 2 diabetes and non-valvular atrial fibrillation (NVAF) newly-initiated on rivaroxaban

Treatment:

Drug: Rivaroxaban (Xarelto, BAY59-7939)

Group B

Description:

Participants with diagnoses of type 2 diabetes and non-valvular atrial fibrillation (NVAF) newly-initiated on warfarin

Treatment:

Drug: Warfarin