A Study to Learn About the Effects of Medicines That Help in Thinning the Blood in People With Atrial Fibrillation (AF) Between 2016 and 2020 in France

Study Overview
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Brief Summary
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The purpose of this study is to look at how many patients with AF had strokes, major bleeding and death in both people who had and had not taken any oral anticoagulant. Atrial fibrillation (AF) is an irregular and often very rapid heart rhythm (arrhythmia) that can lead to blood clots in the heart. This increases the risk of stroke. Anticoagulants are medicines, also called blood thinners, which help prevent blood clots from forming or getting bigger. This study includes patient's data from the database who: Had at least one hospital stay with AF Are new users of OACs for AF treatment Are 18 years and older when they were confirmed to have AF All the patient's data included in this study would have either received the OAC therapy or not. This study aims to look at any events of strokes, major bleeding and death. The data of patients will be collected from the French national health insurance claims database (SNDS). The planned study period is thought to be from 1st January 2016 till 31st December 2020

Official Title
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SIFNOS STUDY: RETROSPECTIVE STUDY IN PATIENTS WITH ATRIAL FIBRILLATION (AF) EXPOSED AND UNEXPOSED TO AN ORAL ANTICOAGULANT THERAPY BETWEEN 2014-2020 IN FRANCE

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Drug: No OAC
* Drug: VKA
* Drug: apixaban
* Drug: rivaroxaban
* Drug: dabigatran


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Identified patients with AF aged 18 years and older at diagnosis of AF Exclusion Criteria: AF Patients with at least one hospital stays for associated valve disease or valve surgery Patients treated with an OAC for another indication than AF

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 |
| --- | --- |
| AF patients unexposed to oral anticoagulants<br> | Drug: No OAC<br>* AF Patient who were not exposed to oral anticoagulation<br>|
| AF patients exposed to VKA<br> | Drug: VKA<br>* AF patients who received VKA<br>|
| AF patients exposed to apixaban<br> | Drug: apixaban<br>* AF patients who received apixaban<br>|
| AF patients exposed to rivaroxaban<br> | Drug: rivaroxaban<br>* AF patients who received rivaroxaban<br>|
| AF patients exposed to dabigatran<br> | Drug: dabigatran<br>* AF patients who received dabigatran<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical outcome in participants | incidence rate of stroke, major bleeding, and death in both non-valvular AF patients exposed to OAC (VKA or DOAC) and unexposed to OAC | up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical outcome in participants | describe the characteristics of non-valvular AF patients exposed and unexposed to OAC | up to 5 years | 
| clinical outcome in participants | compare the incidence of stroke, major bleeding, death | up to 5 years | 
| clinical outcome in participants | Estimation of the annual standardized incidence rate and prevalence | up to 5 years | 
| clinical outcome in participants | Description of OAC treatment patterns | up to 5 years | 
| clinical outcome in participants | Describe the therapeutic management before/after the first stroke occurring after initiation of OAC therapy | up to 5 years | 
| clinical outcome in participants | Comparison of HCRU and associated costs | up to 5 years |