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 @ 2:26 AM
Ignite Modification Date:
2025-12-25 @ 2:26 AM
NCT ID:
NCT04808934
Eligibility Criteria:
Inclusion Criteria:
* Age ≥18 years on the index date.
* At least 1 OAC (apixaban, dabigatran, rivaroxaban, VKAs) dispensed during the identification period.
Exclusion Criteria:
* Specialty of the physician responsible for the OAC prescription in the index date is one of the following: orthopedics, general surgery, vascular surgery or any other surgical specialty;
* Duration of OAC therapy during follow-up inferior to the cut-off defined during the feasibility assessment (except if the patient was admitted to in-hospital care during follow-up);
* The OAC dispensed in the index date was one of the following: dabigatran 75 mg or rivaroxaban 10 mg
* Hospital claims lacking a diagnosis code indicative of AF during the study period;
* Hospital claim indicating a diagnosis or procedure code indicative of pregnancy or childbirth during the study period;
* Hospital claim indicating a diagnosis or procedure code indicative of valvular heart disease, venous thromboembolism, cardiac surgery, pericarditis, hyperthyroidism and thyrotoxicity during the baseline period;
* Hospital claim indicating a diagnosis or procedure code indicative of hip and knee replacement surgery during the 6 weeks prior to the index date. Patients with past use of OAC will be excluded. Therefore, patients meeting any of the following criteria will be excluded:
* Had any OAC (apixaban, dabigatran, edoxaban, rivaroxaban, VKAs) dispensed during the 12-month baseline period;
* Had \>1 OAC dispensed on the index date.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04808934
Study Brief:
Protocol Section:
NCT04808934