Status:
WITHDRAWN
NOAC Portuguese Real World Study
Lead Sponsor:
Pfizer
Conditions:
Stroke
Systemic Embolism
Eligibility:
All Genders
18+ years
Brief Summary
To determine if there is any difference in the effectiveness and safety outcomes of patients with NVAF newly treated with apixaban, dabigatran, rivaroxaban and vitamin K antagonists
Eligibility Criteria
Inclusion
- Age ≥18 years on the index date.
- At least 1 OAC (apixaban, dabigatran, rivaroxaban, VKAs) dispensed during the identification period.
Exclusion
- 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.
Key Trial Info
Start Date :
June 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04808934
Start Date
June 1 2020
End Date
December 1 2020
Last Update
April 5 2023
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