SIFNOS: 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 Details
Study Description
Brief Summary
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
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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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| AF patients unexposed to oral anticoagulants
|
Drug: No OAC
AF Patient who were not exposed to oral anticoagulation
|
| AF patients exposed to VKA
|
Drug: VKA
AF patients who received VKA
|
| AF patients exposed to apixaban
|
Drug: apixaban
AF patients who received apixaban
|
| AF patients exposed to rivaroxaban
|
Drug: rivaroxaban
AF patients who received rivaroxaban
|
| AF patients exposed to dabigatran
|
Drug: dabigatran
AF patients who received dabigatran
|
Outcome Measures
Primary Outcome Measures
- clinical outcome in participants [up to 5 years]
incidence rate of stroke, major bleeding, and death in both non-valvular AF patients exposed to OAC (VKA or DOAC) and unexposed to OAC
Secondary Outcome Measures
- clinical outcome in participants [up to 5 years]
describe the characteristics of non-valvular AF patients exposed and unexposed to OAC
- clinical outcome in participants [up to 5 years]
compare the incidence of stroke, major bleeding, death
- clinical outcome in partcipants [up to 5 years]
Estimation of the annual standardized incidence rate and prevalence
- clinical outcome in participants [up to 5 years]
Description of OAC treatment patterns
- clinical outcome in participants [up to 5 years]
Describe the therapeutic management before/after the first stroke occurring after initiation of OAC therapy
- clinical outcome in partcipants [up to 5 years]
Comparison of HCRU and associated costs
Other Outcome Measures
- clinical outcome in partcicipants [up to 5 years]
Identify subgroups among patients with similar profile with clustering models
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- B0661173
- SIFNOS