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 at a glance

From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

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

ClinicalTrials.gov ID

NCT05838664

Acronym / sponsor ID

SIFNOS / B0661173

Conditions

Atrial Fibrillation

Study type

Observational

Recruitment status

Completed

Enrolment

2,140,403 participants (actual)

Lead sponsor

PfizerIndustry (pharma, biotech, devices)

Study start

7 Jul 2023 (actual)

Primary completion

30 Sep 2024 (actual)

Study completion

30 Sep 2024 (actual)

First posted

1 May 2023 (actual)

Results

Posted 24 Dec 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model

Cohort

Time perspective

Retrospective

Number of arms

5

Who may qualify

Ages

18 years and older

Sex

All

Healthy volunteers

Not accepted

Age groups

Adult, Older adult

Study population

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. Incidence Rate (Per 1000 Participant-years) of Stroke in Non-valvular Atrial Fibrillation (AF) Participants Exposed to Oral Anticoagulation (OAC) and Unexposed to OAC

   Time frame: Follow up period: From index date until death, end of study or the date of last reimbursement of care recorded in the SNDS (maximum up to 48 months); retrospective data was retrieved and analyzed during approximately 9 months of this observational study

   Incidence rate was defined as the number of events occurring during the follow-up period divided by the number of person-years of follow-up (sum of durations of follow-up period for incident participants). Incidence rate of stroke (ischemic or hemorrhage) in non-valvular AF participants who were exposed to OAC or unexposed to OAC were reported in this outcome measure. Index date was the date of the first dispensation of OAC for participants exposed to OAC and for participants unexposed to OAC, index date was the date of inclusion in the study.

2. Incidence Rate (Per 1000 Participant-years) of Major Bleeding in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC

   Time frame: Follow up period: From index date until death, end of study or the date of last reimbursement of care recorded in the SNDS (maximum up to 48 months); retrospective data was retrieved and analyzed during approximately 9 months of this observational study

   Incidence rate was defined as the number of events occurring during the follow-up period divided by the number of person-years of follow-up (sum of durations of follow-up period for incident participants). Incidence rate of major bleeding in non-valvular AF participants who were exposed to OAC or unexposed to OAC were reported in this outcome measure. Index date was the date of the first dispensation of OAC for participants exposed to OAC and for participants unexposed to OAC, index date was the date of inclusion in the study.

3. Incidence Rate (Per 1000 Participant-years) of Death in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC

   Time frame: Follow up period: From index date until death, end of study or the date of last reimbursement of care recorded in the SNDS (maximum up to 48 months); retrospective data was retrieved and analyzed during approximately 9 months of this observational study

   Incidence rate was defined as the number of events occurring during the follow-up period divided by the number of person-years of follow-up (sum of durations of follow-up period for incident participants). Incidence rate of death in non-valvular AF participants who were exposed to OAC or unexposed to OAC were reported in this outcome measure. Index date was the date of the first dispensation of OAC for participants exposed to OAC and for participants unexposed to OAC, index date was the date of inclusion in the study.

4. Number of Participants With Contraindications to OAC at Index Date in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC

   Time frame: At index date (anytime in between 01-Jan-2016 and 31-Dec-2019); retrospective data was retrieved and analyzed during approximately 9 months of this observational study

   Contraindications included end-stage renal disease on dialysis, diseases of the blood and blood-forming organs, certain disorders involving the immune mechanism, recent history of acute bleeding gastric or duodenal ulcer, hepatic cirrhosis or fibrosis or liver failure. Index date was the date of the first dispensation of OAC for participants exposed to OAC and for participants unexposed to OAC, index date was the date of inclusion in the study.

5. Number of Participants Who Received Complimentary Universal Health Care (CMU-c) in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC

   Time frame: At index date (anytime in between 01-Jan-2016 and 31-Dec-2019); retrospective data was retrieved and analyzed during approximately 9 months of this observational study

   A participant was considered to have received CMU-c if the participant benefitted from an exemption from care on the grounds of CMU-c for care received on the index date. Index date was the date of the first dispensation of OAC for participants exposed to OAC and for participants unexposed to OAC, index date was the date of inclusion in the study.

6. Number of Participants Who Received Aid for Complementary Health Care (ACS) for Elderly Participants in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC

   Time frame: At index date (anytime in between 01-Jan-2016 and 31-Dec-2019); retrospective data was retrieved and analyzed during approximately 9 months of this observational study

   A participant was considered to have received ACS if the participant benefitted from an aid for complementary health care on the index date. Index date was the date of the first dispensation of OAC for participants exposed to OAC and for participants unexposed to OAC, index date was the date of inclusion in the study.

7. Number of Participants Classified as Per Area of Residence in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC

   Time frame: At index date (anytime in between 01-Jan-2016 and 31-Dec-2019); retrospective data was retrieved and analyzed during approximately 9 months of this observational study

   Area of residence was derived based on the code of the department of residence recorded with health cares carried out on index date. Index date was the date of the first dispensation of OAC for participants exposed to OAC and for participants unexposed to OAC, index date was the date of inclusion in the study.

8. Number of Participants Classified as Per Modified CHA2DS2-VASc Score in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC

   Time frame: At index date (anytime in between 01-Jan-2016 and 31-Dec-2019); retrospective data was retrieved and analyzed during approximately 9 months of this observational study

   Congestive heart failure, hypertension, age (>65 = 1 point, >75 = 2 points), diabetes, previous stroke/transient ischemic attack (2 points) (CHA2DS2)-vascular disease and sex category (VASc) scoring scale was used to estimate the risk of stroke and systemic emboli in participants with NVAF. CHA2DS2-VASc score was calculated based on 8 risk factors (age 65-74 years, age >=75 years, sex category, congestive heart failure history, hypertension history, stroke/transient ischemic attack/thromboembolism history, vascular disease history and diabetes mellitus history). Total CHA2DS2-VASc score ranged from 0-9 where 0= low risk and 9= high risk of stroke, higher scores indicated higher risk of stroke and systemic emboli. Index date was date of first dispensation of OAC for participants exposed to OAC and for participants unexposed to OAC, index date was the date of inclusion in the study.

9. HAS-BLED Score in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC

   Time frame: At index date (anytime in between 01-Jan-2016 and 31-Dec-2019); retrospective data was retrieved and analyzed during approximately 9 months of this observational study

   HAS-BLED scoring scale was used to estimate the risk of bleeding. HAS-BLED score was calculated based on 9 risk factors (hypertension, renal disease, liver disease, stroke history, prior major bleeding or predisposition to bleeding, labile international normalized ratio (INR), age >65 years, medication usage predisposing to bleeding and alcohol use). Total HAS-BLED score ranged from 0 to 9 where 0 = low risk and >=3 = high risk of bleed, higher scores indicated more risk of bleeds. Index date was the date of the first dispensation of OAC for participants exposed to OAC and for participants unexposed to OAC, index date was the date of inclusion in the study.

10. Number of Participants Classified as Per Type of Stroke in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC

    Time frame: At index date (anytime in between 01-Jan-2016 and 31-Dec-2019); retrospective data was retrieved and analyzed during approximately 9 months of this observational study

    Type of stroke was considered "Yes" if the participant was hospitalized with any discharge diagnosis (i.e., main and related diagnosis) of stroke (ischemic or hemorrhagic). Index date was the date of the first dispensation of OAC for participants exposed to OAC and for participants unexposed to OAC, index date was the date of inclusion in the study.

11. Number of Participants With Risk of Falls in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC

    Time frame: At index date (anytime in between 01-Jan-2016 and 31-Dec-2019); retrospective data was retrieved and analyzed during approximately 9 months of this observational study

    Participants at risk of falls were identified by an algorithm adapted to SNDS data. Index date was the date of the first dispensation of OAC for participants exposed to OAC and for participants unexposed to OAC, index date was the date of inclusion in the study.

12. Number of Participants Who Were Polymedicated in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC

    Time frame: Up to 1 year prior to index date (index date was anytime in between 01-Jan-2016 and 31-Dec-2019); retrospective data was retrieved and analyzed during approximately 9 months of this observational study

    Participant was considered polymedicated if the participant had reimbursements for greater than or equal to (>=) 5 different medications (different Anatomical Therapeutic Chemical codes [ATC] in the year before the index date. Index date was the date of the first dispensation of OAC for participants exposed to OAC and for participants unexposed to OAC, index date was the date of inclusion in the study.

13. Number of Participants With Atleast One Visit to Nursing Home in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC

    Time frame: Up to 2 years prior to index date (index date was anytime in between 01-Jan-2016 and 31-Dec-2019); retrospective data was retrieved and analyzed during approximately 9 months of this observational study

    Participant was considered to have at least one visit to nursing home if the participant had at least one reimbursement corresponding to a nursing home on or in the 2 years prior to the index date. Index date was the date of the first dispensation of OAC for participants exposed to OAC and for participants unexposed to OAC, index date was the date of inclusion in the study.

14. Age Adjusted Charlson Comorbidity Index (CCI) in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC

    Time frame: At index date (anytime in between 01-Jan-2016 and 31-Dec-2019); retrospective data was retrieved and analyzed during approximately 9 months of this observational study

    CCI based on various comorbid conditions such as myocardial infarction, congestive heart failure (CHF), peripheral vascular disease, cerebrovascular disease, dementia, chronic obstructive pulmonary disease, rheumatologic disease, peptic ulcer disease, mild liver disease, diabetes (mild to moderate), diabetes + complications, hemiplegia or paraplegia, renal disease, any malignancy (lymphoma and leukemia), moderate/severe liver disease, metastatic solid tumor, and acquired immune deficiency syndrome (AIDS) were reported. The comorbidities were assessed with different weights (from 1 to 6), and the total score was determined by adding the scores of each comorbidity. CCI score range was from 0 to 14, where 0= low comorbid condition and 14= high comorbid condition, higher scores= more comorbidity. Index date = date of the first dispensation of OAC for participants exposed to OAC and for participants unexposed to OAC, index date was the date of inclusion in the study.

15. Number of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC

    Time frame: At index date (anytime in between 01-Jan-2016 and 31-Dec-2019); retrospective data was retrieved and analyzed during approximately 9 months of this observational study

    The number of participants classified as per comorbidities (coronary arterial diseases, vascular and neurodegenerative dementia, myocardial infarction, congestive heart failure, peripheral arterial disease, other vascular diseases, sleep disorders, active cancer, malnutrition, morbid obesity, anemia, chronic obstructive pulmonary disease, diabetes, diabetes with complication, connective tissue disease, ulcer disease, cerebrovascular disease, cerebrovascular disease, mild liver disease, moderate-to-severe liver disease, hemiplegia) in non-valvular AF participants who were exposed to OAC and unexposed to OAC were reported in this outcome measure. One participant could have more than one comorbidity. Index date was the date of the first dispensation of OAC for participants exposed to OAC and for participants unexposed to OAC, index date was the date of inclusion in the study.

Results and safety

Loading the posted results from ClinicalTrials.gov…

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
• Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
• To obtain contact information for a study center near you, click here.Link provided by the sponsor.
• Individual participant dataSharing planned: No. 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

1 site in 1 country: see every site and its status.