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NOAC Portuguese Real World Study
NOAC Portuguese Real World Study

NCT04808934

WithdrawnN/A

Sponsor: Pfizer

Conditions: Stroke, Systemic Embolism, Major Bleeding

Interventions: Apixaban, dabigatran, rivaroxaban, VKAs

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 overview

Sex: ALL

Age: 18 Years to

Healthy volunteers: No

Study type: OBSERVATIONAL

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.