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Completed

NCT Number: NCT04509193

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

US Optum De-Identified EHR data

Whippany, New Jersey, 07981, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rivaroxaban (Xarelto, BAY59-7939)

Drug

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

Warfarin

Drug

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

Primary outcomes

  1. Composite of stroke or systemic embolism

    Time frame: Up to 8 years

  2. Any major or clinically-relevant nonmajor bleed resulting in hospitalization

    Time frame: Up to 8 years

Secondary outcomes

  1. Ischemic stroke

    Time frame: Up to 8 years

  2. Systemic embolism

    Time frame: Up to 8 years

  3. Need for revascularization or major amputation of the lower limb

    Time frame: Up to 8 years

  4. Intracranial hemorrhage

    Time frame: Up to 8 years

  5. Critical organ bleeding per ISTH categories

    Time frame: Up to 8 years

    The categories for critical organ bleeding as per ISTH definition are: intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome.

  6. Any extracranial bleeding

    Time frame: Up to 8 years

  7. 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

    Time frame: Up to 8 years

  8. Doubling of the serum creatinine level from baseline

    Time frame: Up to 8 years

  9. Decrease in eGFR>30% or 40%

    Time frame: Up to 8 years

    Glomerular filtration rate (GRF)

  10. Development of an eGFR<15 mL/min or initiation of dialysis

    Time frame: Up to 8 years

    Glomerular filtration rate (GRF)

  11. Development of end-stage renal disease per billing codes only

    Time frame: Up to 8 years

  12. Development of urine albumin-to-creatinine ratio (UACR) of 30-300 or >300

    Time frame: Up to 8 years

  13. Development of serum potassium > 5.6 or >6 mg/dL

    Time frame: Up to 8 years

  14. Development of diabetic retinopathy

    Time frame: Up to 8 years

  15. Myocardial infarction

    Time frame: Up to 8 years

  16. All-cause mortality

    Time frame: Up to 8 years

  17. Vascular mortality

    Time frame: Up to 8 years

  18. Major adverse cardiovascular event

    Time frame: Up to 8 years

  19. Composite of stroke, systemic embolism, vascular death

    Time frame: Up to 8 years

  20. Composite of stroke, systemic embolism, myocardial infarction, vascular death

    Time frame: Up to 8 years

  21. Composite stroke, systemic embolism, need for lower limb revascularization or major amputation

    Time frame: Up to 8 years

  22. 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

    Time frame: Up to 8 years

    Glomerular filtration rate (GRF)

  23. New-onset vascular dementia

    Time frame: Up to 8 years

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

  • Janssen Research & Development, LLC

Registry information

Official study title

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

Acronym: RIVA-DM

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 11, 2020
Registry last updated
Jun 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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