check_circleStudy Completed

Atrial fibrillation

Bayer Identifier:

21449

ClinicalTrials.gov Identifier:

NCT04509193

EudraCT Number:

Not Available

EU CT Number:

Not Available
A study using electronic health information to learn about rivaroxaban compared to warfarin in participants with non-valvular atrial fibrillation (NVAF) and diabetes

Trial purpose

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.

Key Participants Requirements

Sex

All

Age

18 - N/A
  • - 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
  • - 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 summary

Enrollment Goal
116049
Trial Dates
August 2020 - July 2021
Phase
Phase 4
Could I Receive a placebo
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
US Optum De-Identified EHR dataWhippany, 07981, United States

Primary Outcome

  • Composite of stroke or systemic embolism
    date_rangeTime Frame:
    Up to 8 years
  • Any major or clinically-relevant nonmajor bleed resulting in hospitalization
    date_rangeTime Frame:
    Up to 8 years

Secondary Outcome

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

Trial design

RIVA-DM: Effectiveness and Safety of Rivaroxaban vs. Warfarin in Nonvalvular Atrial Fibrillation and Diabetes Mellitus: Analysis of Electronic Health Record Data
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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