NOAC Portuguese Real World Study

Pfizer

Status

Withdrawn

Conditions

Major Bleeding

Stroke

Systemic Embolism

Treatments

Drug: VKAs

Drug: dabigatran

Drug: rivaroxaban

Drug: Apixaban

Study type

Observational

Funder types

Industry

Identifiers

NCT04808934

X9001275

Details and patient eligibility

About

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

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.