N/A
N=2,140,403
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
Bottom Line
View on ClinicalTrials.gov: NCT05838664 ↗Enrolled (actual)
2,140,403
Serious AEs
—
Results posted
Dec 2025
Primary outcome: Primary: Incidence Rate (Per 1000 Participant-years) of Stroke in Non-valvular Atrial Fibrillation (AF) Participants Exposed to Oral Anticoagulation (OAC) and Unexposed to OAC — 14.7; 31.2 Events per 1000 person years
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- No OAC (Drug); VKA (Drug); apixaban (Drug); rivaroxaban (Drug); dabigatran (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Sep 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence Rate (Per 1000 Participant-years) of Stroke in Non-valvular Atrial Fibrillation (AF) Participants Exposed to Oral Anticoagulation (OAC) and Unexposed to OAC |
14.7; 31.2 | — |
| PRIMARY Incidence Rate (Per 1000 Participant-years) of Major Bleeding in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC |
21.5; 23.6 | — |
| PRIMARY Incidence Rate (Per 1000 Participant-years) of Death in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC |
41.1; 184.6 | — |
| PRIMARY Number of Participants With Contraindications to OAC at Index Date in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC |
49478; 86646 | — |
| PRIMARY Number of Participants Who Received Complimentary Universal Health Care (CMU-c) in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC |
12819; 10198 | — |
| PRIMARY 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 |
10444; 8698 | — |
| PRIMARY Number of Participants Classified as Per Area of Residence in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC |
56168; 34422; 24185; 13849; 25892; 15574 | — |
| PRIMARY Number of Participants Classified as Per Modified CHA2DS2-VASc Score in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC |
402191; 281168; 57481; 30413; 25974; 20655 | — |
| PRIMARY HAS-BLED Score in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC |
2.26; 2.5 | — |
| PRIMARY Number of Participants Classified as Per Type of Stroke in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC |
1285; 5614; 1025; 3996; 36313; 38642 | — |
| PRIMARY Number of Participants With Risk of Falls in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC |
186288; 170465 | — |
| PRIMARY Number of Participants Who Were Polymedicated in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC |
408403; 291508 | — |
| PRIMARY Number of Participants With Atleast One Visit to Nursing Home in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC |
16170; 31493 | — |
| PRIMARY Age Adjusted Charlson Comorbidity Index (CCI) in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC |
2.32; 3.6 | — |
| PRIMARY Number of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC |
86531; 75022; 23398; 46852; 12063; 8689 | — |
| SECONDARY Number of Participants With Concomitant Treatments in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC |
330710; 124236; 354602; 198727; 206611; 150062 | — |
| SECONDARY Annual Incidence Rate of Non-valvular AF in Participants Exposed to OAC and Unexposed to OAC |
4.31; 1.75; 4.13; 1.59; 3.86; 1.38 | — |
| SECONDARY Annual Prevalence (Prevalent Cases Per 1000 Years) of Non-valvular AF in Participants Exposed to OAC and Unexposed to OAC |
1.50; 0.53; 1.76; 0.65; 1.97; 0.75 | — |
| SECONDARY Number of Participants Who Were New Users of OAC and VKA |
421313; 0 | — |
| SECONDARY Number of Participants According to Number of Treatment Sequence |
451539; 120751 | — |
| SECONDARY Duration of Each Sequence of OAC Treatment |
9.5; 6.9 | — |
| SECONDARY Number of Participants With Treatment Switch of OAC Treatment |
48101; 8592 | — |
| SECONDARY Number of Participants With Temporary or Permanent Treatment Discontinuation of OAC |
167099; 40849 | — |
| SECONDARY Number of Participants Classified According to Type of OAC Delivery for Participants Exposed to OACs |
245094; 151288; 56632; 32632 | — |
| SECONDARY Number of Participants According to Speciality of Prescriber for Participant Exposed to OAC |
222102; 100629; 134893; 114252; 414; 27905 | — |
| SECONDARY Mean Number of Hospital Stays Per Participant Per Month Before the First Stroke From 6 to 12 Months |
0.2; 0.2 | — |
| SECONDARY Mean Number of Outpatient Visits Per Participant Per Month Before the First Stroke From 6 to 12 Months |
1.1; 1.0; 29.7; 20.3; 0.2; 0.1 | — |
| SECONDARY Mean Number of Laboratory Tests Per Participant Per Month (PPPM) Before the First Stroke From 6 to 12 Months |
1.0; 0.5 | — |
| SECONDARY Mean Number of Medical Procedures Per Participant Per Month Before the First Stroke From 6 to 12 Months |
0.5; 0.5 | — |
| SECONDARY Mean Number of Reimbursed Transports Per Participant Per Month Before the First Stroke From 6 to 12 Months |
0.4; 0.3 | — |
| SECONDARY Mean Number of Drugs Dispensed Per Participant Per Month Before the First Stroke From 6 to 12 Months |
11.6; 9.1 | — |
| SECONDARY Mean Number of Medical Devices Dispensed Per Participant Per Month Before the First Stroke From 6 to 12 Months |
0.8; 0.6 | — |
| SECONDARY Mean Number of Hospital Stays Per Participant Per Month After the First Stroke From 6 to 12 Months |
0.2; 0.3 | — |
| SECONDARY Mean Number of Outpatient Visits Per Participant Per Month After the First Stroke From 6 to 12 Months |
1.0; 0.9; 35.3; 29.4; 0.2; 0.2 | — |
| SECONDARY Mean Number of Laboratory Tests Per Participant Per Month After the First Stroke From 6 to 12 Months |
0.9; 0.6 | — |
| SECONDARY Mean Number of Outpatient Medical Procedures Per Participant Per Month of HCRU After the First Stroke From 6 to 12 Months |
0.5; 0.4 | — |
| SECONDARY Mean Number of Reimbursed Transports Per Participant Per Month of HCRU After the First Stroke From 6 to 12 Months |
0.5; 0.6 | — |
| SECONDARY Mean Number of Drugs Dispensed Per Participant Per Month After the First Stroke From 6 to 12 Months |
11.9; 9.2 | — |
| SECONDARY Mean Number of Medical Devices Dispensed Per Participant Per Month After the First Stroke From 6 to 12 Months |
1.0; 1.0 | — |
| SECONDARY Hospitalization Cost in Participants Exposed to and Unexposed to OAC |
434.1; 1318.5 | — |
| SECONDARY Medical Procedures and Blood Examination Cost in Participants Exposed to and Unexposed to OAC |
33.1; 28.2; 14.3; 11.2 | — |
| SECONDARY Mean Number of Hospital Stays Per Month |
0.2; 0.4; 0.0; 0.1; 0.0; 0.0 | — |
| SECONDARY Mean Number of Emergency Visits Per Month |
0.0; 0.0 | — |
| SECONDARY Mean Number of Physician Visits |
1.0; 0.8 | — |
| SECONDARY Mean Number of Public Hospital Outpatient Visits |
0.2; 0.2 | — |
| SECONDARY Mean Number of Paramedic Visits in Community Setting |
28.8; 23.4 | — |
| SECONDARY Mean Number of Laboratory Tests |
0.8; 0.5 | — |
| SECONDARY Mean Number of Outpatient Medical Procedures |
0.6; 0.5 | — |
| SECONDARY Mean Number of Travels Per Month |
0.3; 0.4 | — |
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
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT05838664). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.