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 (SIFNOS)

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Drug: No OAC; Drug: VKA; Drug: apixaban; Drug: rivaroxaban; Drug: dabigatran

• Study Type: Observational
• Enrollment (Estimated): 1

Contacts and Locations

• Study Contact: Name: Pfizer CT.gov Call Center; Phone Number: 1-800-718-1021; Email: ClinicalTrials.gov_Inquiries@pfizer.com

Study Locations

• France
  • Paris, France
    • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

18 years old AF Patients and older will be included from January 1st, 2016 to December 31st, 2020:

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

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	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	Estimation of the annual standardized incidence rate and prevalence	up to 5 years
clinical outcome in participants	Comparison of HCRU and associated costs	up to 5 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical outcome in participants	Identify subgroups among patients with similar profile with clustering models	up to 5 years

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2023
• Primary Completion (Estimated): March 31, 2024
• Study Completion (Estimated): March 31, 2024

Study Registration Dates

• First Submitted: March 28, 2023
• First Submitted That Met QC Criteria: April 28, 2023
• First Posted (Actual): May 1, 2023

Study Record Updates

• Last Update Posted (Actual): September 18, 2023
• Last Update Submitted That Met QC Criteria: September 15, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Rivaroxaban; Dabigatran; Apixaban
• Other Study ID Numbers: B0661173; SIFNOS (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No