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

NCT04509193 | Completed

• 2 other identifiers: 21449EUPAS36634
• Study Type: observational
• Target: 116,049
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

• Composite of stroke or systemic embolism

  Up to 8 years

• Any major or clinically-relevant nonmajor bleed resulting in hospitalization

  Up to 8 years

Secondary Outcomes (23)

• Ischemic stroke

  Up to 8 years

• Systemic embolism

  Up to 8 years

• Need for revascularization or major amputation of the lower limb

  Up to 8 years

• Intracranial hemorrhage

  Up to 8 years

• Critical organ bleeding per ISTH categories

  Up to 8 years

Study Arms (2)

Group A

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

Drug: Rivaroxaban (Xarelto, BAY59-7939)

Group B

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

Drug: Warfarin

Interventions

Rivaroxaban (Xarelto, BAY59-7939) DRUG

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

Group A

Warfarin DRUG

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

Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead
• Janssen Research & Development, LLC: collaborator

Study Sites (1)

US Optum De-Identified EHR data

Whippany, New Jersey, 07981, United States

Location

Related Publications (1)

• 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.

  PMID: 34166150 DERIVED

Related Links

• Click here to find results for studies related to Bayer products

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Rivaroxaban; Warfarin

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; 4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2020
• First Posted: August 11, 2020
• Study Start: August 21, 2020
• Primary Completion: July 31, 2021
• Study Completion: July 31, 2021
• Last Updated: June 15, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)