NCT04509193

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 116,049 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
DRUG	Rivaroxaban (Xarelto, BAY59-7939)	Participants receive rivaroxaban (per written prescription, medication administration or self-report of medication use)
DRUG	Warfarin	Participants receive warfarin (per written prescription, medication administration or self-report of medication use)

Timeline

• Start date: 2020-08-21
• Primary completion: 2021-07-31
• Completion: 2021-07-31
• First posted: 2020-08-11
• Last updated: 2022-06-15

Locations

1 site across 1 country: United States