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:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2025-12-24 @ 9:08 PM
NCT ID:
NCT05051904
Eligibility Criteria:
Inclusion Criteria:
-≥18 years of age
* Has one year of look-back period prior to the index date (defined as the first date of prescription for dabigatran, rivaroxaban, or warfarin during the study period)
* New users of warfarin, dabigatran, and rivaroxaban, defined as patients without historic use of any oral anticoagulants during the look-back period
* Has at least 1 diagnosis of NVAF during the look-back period prior to or on the index date
* Has at least 1 diagnosis of CAD during the look-back period prior to or on the index date
Exclusion Criteria:
* Diagnosed with end-stage renal disease, or undergo hemodialysis, or experience pregnancy during the study period
* Initiate warfarin, dabigatran, rivaroxaban due to valvular Atrial Fibrillation (AF), AF associated with mechanical valve malfunction or mechanical complication of heart valve prosthesis, or rheumatic AF
* Underwent joint replacement procedures or diagnosed with venous thromboembolism during the look-back period prior to or on the index date
* Prescribed with more than 1 oral anticoagulation (OAC) on the index date
* Prescribed with more than 2 anti-platelet drugs per prescription (triple or quadruple anti-platelet use), or prescribed with any anti-platelet injection
* Patients with missing or ambiguous age or sex information
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05051904
Study Brief:
Protocol Section:
NCT05051904