Real Evidence of Anticoagulation Treatment in Non-valvular Atrial Fibrillation in Germany, UK and France: REACT-AF2

Study Overview
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Brief Summary
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The purpose of this study is to determine and compare the persistence rate of newly prescribed apixaban, rivaroxaban, dabigatran and VKAs in patients with NVAF.

Detailed Description
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Actual number of patients enrolled for UK : 15242 patients Actual number of patients enrolled for Germany : 22880 patients

Official Title
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Real Evidence of Anticoagulation Treatment in Non-valvular Atrial Fibrillation in Germany, UK and France: REACT-AF 2

Conditions
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Non-valvular Atrial Fibrillation

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have an apixaban, rivaroxaban, dabigatran or VKA prescription during the study period Are ≥18 years old at index date Have ≥12 months of computerised medical data prior to index date Have a record of AF on or ever prior to index date (index OAC prescription) Exclusion Criteria: Have a record for a valvular condition (ie, rheumatic valvular disease and prosthetic valves) on or ever prior to index date Have a history (ever prior to index date) of the Oral anticoagulant (OACs) which are prescribed during the study period

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patient treated with Apixaban<br> | |
| Patient treated with Rivaroxaban<br> | |
| Patient treated with Dabigatran<br> | |
| Patient treated with vitamin K antagonists<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Persistence rate of newly prescribed apixaban, rivaroxaban, dabigatran and vitamin K antagonists (VKAs) in patients with non-valvular atrial fibrillation(NVAF) | We defined non-persistence in the databases as the absence of index prescription for twice the median prescription duration; and calculated cumulative incidence (95% CIs) of persistence at the end of follow-up and at different time points after treatment initiation (3, 6, and 12 months) | 23 months for the UK and Germany, 25 months for France | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demographic characteristics (Age, Gender, Smoking status, region of practice, data source) of patients with newly prescribed oral anticoagulants |  | 23 months for the UK and Germany, 25 months for France | 
| Clinical characteristics (History of bleeding, myocardial infarction, stroke, Thromboembolism, congestive heart failure, vascular disease, hypertension, CHA2DS2-VASc score, HAS-BLED score, etc) of patients with newly prescribed oral anticoagulants |  | 23 months for the UK and Germany, 25 months for France | 
| Adherence to newly prescribed oral anticoagulants based on Medication possession ratio (MPR) |  | 23 months for the UK and Germany | 
| Compare persistence rates across oral anticoagulant therapies |  | 23 months for the UK and Germany, 25 months for France |