Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2025-12-25 @ 1:20 AM
NCT ID:
NCT04509193
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04509193
Study Brief:
Protocol Section:
NCT04509193