CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 2,140,403 enrolled
Drug / intervention
No OAC +4 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05838664
NCT05838664N/ACompleted

SIFNOS STUDY: RETROSPECTIVE STUDY IN PATIENTS WITH ATRIAL FIBRILLATION (AF) EXPOSED AND UNEXPOSED TO AN ORAL ANTICOAGULANT THERAPY BETWEEN 2016-2020 IN FRANCE

Pfizer·observational·Posted May 1, 2023·Updated Dec 24, 2025

In Brief

An observational study evaluating No OAC, VKA, and 3 other interventions for Atrial Fibrillation. Completed, enrolled 2,140,403 participants across 1 site.

Detailed 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

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesFrance
Collaborators--

Timeline

N/ACompletedFinished
202420252026
First PostedMay 1, 2023
Enrollment StartJul 7, 2023
Primary CompletionSep 30, 2024
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 3.2 years ago

Interventions

No OACdrug

AF Patient who were not exposed to oral anticoagulation

VKAdrug

AF patients who received VKA

apixabandrug

AF patients who received apixaban

rivaroxabandrug

AF patients who received rivaroxaban

dabigatrandrug

AF patients who received dabigatran