Status:
COMPLETED
A Study Using Electronic Health Information to Learn About Rivaroxaban Compared to Warfarin in Participants With Non-valvular Atrial Fibrillation (NVAF) and Diabetes
Lead Sponsor:
Bayer
Collaborating Sponsors:
Janssen Research & Development, LLC
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18+ years
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 t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 21 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 31 2021
Estimated Enrollment :
116049 Patients enrolled
Trial Details
Trial ID
NCT04509193
Start Date
August 21 2020
End Date
July 31 2021
Last Update
June 15 2022
Active Locations (1)
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1
US Optum De-Identified EHR data
Whippany, New Jersey, United States, 07981