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Atrial FibrillationRIVA-DMNCT04509193

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

An observational study of Atrial Fibrillation, run by Bayer at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atrial Fibrillation
What is being tested?
Rivaroxaban (Xarelto, BAY59-7939) and Warfarin
How many people
116,049 participants
Where
1 siteUnited States
Study dates
21 Aug 2020to 31 Jul 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

United States1 site

  • US Optum De-Identified EHR data

    Whippany, New Jersey, 07981

Other trials in United States

About this study

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

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.

Read more

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.

Being tested
Rivaroxaban (Xarelto, BAY59-7939), Warfarin
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rivaroxaban (Xarelto, BAY59-7939)Drug

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

  • WarfarinDrug

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

Study groups in NCT04509193
Study groupRoleWhat they receive
Group AParticipants with diagnoses of type 2 diabetes and non-valvular atrial fibrillation (NVAF) newly-initiated on rivaroxaban
Receives: Drug: Rivaroxaban (Xarelto, BAY59-7939)
Group BParticipants with diagnoses of type 2 diabetes and non-valvular atrial fibrillation (NVAF) newly-initiated on warfarin
Receives: Drug: Warfarin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Composite of stroke or systemic embolism

    Measured: Up to 8 years

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

    Measured: Up to 8 years

Secondary outcomes (23)

  1. Ischemic stroke

    Measured: Up to 8 years

  2. Systemic embolism

    Measured: Up to 8 years

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

    Measured: Up to 8 years

  4. Intracranial hemorrhage

    Measured: Up to 8 years

  5. 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.

    Measured: Up to 8 years

  6. Any extracranial bleeding

    Measured: 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

    Measured: Up to 8 years

  8. Doubling of the serum creatinine level from baseline

    Measured: Up to 8 years

  9. Decrease in eGFR>30% or 40%

    Glomerular filtration rate (GRF)

    Measured: Up to 8 years

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

    Glomerular filtration rate (GRF)

    Measured: Up to 8 years

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

    Measured: Up to 8 years

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

    Measured: Up to 8 years

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

    Measured: Up to 8 years

  14. Development of diabetic retinopathy

    Measured: Up to 8 years

  15. Myocardial infarction

    Measured: Up to 8 years

  16. All-cause mortality

    Measured: Up to 8 years

  17. Vascular mortality

    Measured: Up to 8 years

  18. Major adverse cardiovascular event

    Measured: Up to 8 years

  19. Composite of stroke, systemic embolism, vascular death

    Measured: Up to 8 years

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

    Measured: Up to 8 years

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

    Measured: 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

    Glomerular filtration rate (GRF)

    Measured: Up to 8 years

  23. New-onset vascular dementia

    Measured: Up to 8 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Aug 2020
  2. Study start21 Aug 2020
  3. Primary completion31 Jul 2021
  4. Study completion31 Jul 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
116,049 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04509193
Sponsor's protocol ID
21449
Other IDs
EUPAS36634
Acronym
RIVA-DM
Status last verified
Jun 2022
First submitted
10 Aug 2020
Last updated
15 Jun 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

Publications

  • 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.

    PubMed 34166150

Questions about this trial

What is this clinical trial studying?

An observational study of Atrial Fibrillation, run by Bayer at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite of stroke or systemic embolism (time frame: Up to 8 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04509193, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2022; AzTrials last refreshed its copy on 31 Oct 2026.

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