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

Atrial Fibrillation Clinical Trial

— SIFNOS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05838664
• Other study ID #: B0661173
• Secondary ID: SIFNOS
• Status: Completed
• Start date: July 7, 2023
• Est. completion date: March 31, 2024

Study information

• Verified date: May 2024
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

• 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3691397
• Est. completion date: March 31, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• No OAC
AF Patient who were not exposed to oral anticoagulation
• VKA
AF patients who received VKA
• apixaban
AF patients who received apixaban
• rivaroxaban
AF patients who received rivaroxaban
• dabigatran
AF patients who received dabigatran

Locations

Country	Name	City	State
France	Pfizer Investigational Site	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	clinical outcome in participants	Identify subgroups among patients with similar profile with clustering models	up to 5 years
Primary	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	clinical outcome in participants	describe the characteristics of non-valvular AF patients exposed and unexposed to OAC	up to 5 years
Secondary	clinical outcome in participants	compare the incidence of stroke, major bleeding, death	up to 5 years
Secondary	clinical outcome in participants	Estimation of the annual standardized incidence rate and prevalence	up to 5 years
Secondary	clinical outcome in participants	Description of OAC treatment patterns	up to 5 years
Secondary	clinical outcome in participants	Describe the therapeutic management before/after the first stroke occurring after initiation of OAC therapy	up to 5 years
Secondary	clinical outcome in participants	Comparison of HCRU and associated costs	up to 5 years

External Links

•   To obtain contact information for a study center near you, click here.