NOAC Portuguese Real World Study

Study Overview
=================
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

Official Title
-----------------
Stroke/Systemic Embolism and Major Bleeding in Patients Newly Treated With Oral Anticoagulants: a Real World Study From Portuguese Administrative Claims Data

Conditions
-----------------
Stroke, Systemic Embolism, Major Bleeding

Intervention / Treatment
-----------------
* Drug: Apixaban
* Drug: dabigatran
* Drug: rivaroxaban
* Drug: VKAs


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Non-Valvular Atrial Fibrillation (NVAF) Adults<br>Adult patients with NVAF newly treated with apixaban, dabigatran, rivaroxaban or VKAs between June 16, 2014 and December 31, 2018. | Drug: Apixaban<br>* Adults receiving apixaban<br>Drug: dabigatran<br>* Adults receiving dabigatran<br>Drug: rivaroxaban<br>* Adults receiving rivaroxaban<br>Drug: VKAs<br>* Adults receiving VKA<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| stroke/systemic embolism event | 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. | between 2014 and 2018 | 
| major bleeding event | 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. | between 2014 and 2018 | 

Secondary Outcome Measures

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