NOAC Portuguese Real World Study

Withdrawn

• Conditions: Stroke; Systemic Embolism; Major Bleeding
• Interventions: Drug: Apixaban; Drug: dabigatran; Drug: rivaroxaban; Drug: VKAs

• Registration Number: NCT04808934
• Lead Sponsor: Pfizer

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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-01
• Primary Completion: 2020-12-01
• Study Completion: 2020-12-01
• Study First Submitted: 2021-03-18
• Study First Submitted QC: 2021-03-18
• Study First Posted: 2021-03-22
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-04
• Last Update Posted: 2023-04-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non-Valvular Atrial Fibrillation (NVAF) Adults	VKAs	Adult patients with NVAF newly treated with apixaban, dabigatran, rivaroxaban or VKAs between June 16, 2014 and December 31, 2018.
Non-Valvular Atrial Fibrillation (NVAF) Adults	Apixaban	Adult patients with NVAF newly treated with apixaban, dabigatran, rivaroxaban or VKAs between June 16, 2014 and December 31, 2018.
Non-Valvular Atrial Fibrillation (NVAF) Adults	dabigatran	Adult patients with NVAF newly treated with apixaban, dabigatran, rivaroxaban or VKAs between June 16, 2014 and December 31, 2018.
Non-Valvular Atrial Fibrillation (NVAF) Adults	rivaroxaban	Adult patients with NVAF newly treated with apixaban, dabigatran, rivaroxaban or VKAs between June 16, 2014 and December 31, 2018.

Primary Outcome Measures

Name	Time	Method
stroke/systemic embolism event	between 2014 and 2018	To compare the risk of stroke (either ischemic or hemorrhagic) or SE among patients newly treated with each NOAC separately (apixaban, dabigatran, rivaroxaban) versus VKAs.
major bleeding event	between 2014 and 2018	To compare the risk of major bleeding (gastrointestinal \[GI\], intracranial \[IC\] and other) among patients newly treated with each NOAC separately (apixaban, dabigatran, rivaroxaban) versusVKAs.

Secondary Outcome Measures

Name	Time	Method
systemic embolism event	2014-2018	To compare the risk of systemic embolism among patients newly treated with each NOAC separately (apixaban, dabigatran, rivaroxaban) versus VKAs.
other major bleeding event	2014-2018	To compare the risk of other major bleeding among patients newly treated with each NOAC separately (apixaban, dabigatran, rivaroxaban) versus VKAs.
major GI bleeding event	2014-2018	To compare the risk of major GI bleeding among patients newly treated with each NOAC separately (apixaban, dabigatran, rivaroxaban) versus VKAs.
ischemic stroke event	between 2014 and 2018	To compare the risk of ischemic stroke among patients newly treated with each NOAC separately (apixaban, dabigatran, rivaroxaban) versus VKAs.
hemorrhagic stroke event	between 2014 and 2018	To compare the risk of hemorrhagic stroke among patients newly treated with each NOAC separately (apixaban, dabigatran, rivaroxaban) versus VKAs.
major IC bleeding event	2014-2018	To compare the risk of major IC bleeding among patients newly treated with each NOAC separately (apixaban, dabigatran, rivaroxaban) versus VKAs.