Atrial FibrillationANTITHROMBOTEANCT04932603
Multidisciplinary Team Approach to Prescribe Antithrombotic Therapy in Older People With Atrial Fibrillation
An observational study of Atrial Fibrillation, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Antithrombotic drugs, which include antiplatelet and anticoagulant therapies, are used to prevent and treat many cardiovascular disorders. With the increase in prevalence of cardiovascular diseases and medical progress, these treatments are increasingly being prescribed, particularly in older patients. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 833 participants
- Where
- 1 siteFrance
- Study dates
- 29 May 2021to 5 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients hospitalized in 6 geriatrics units in the Greater Paris area and / or whose clinical file is reviewed by the multidisciplinary team PAtiet
Who may be able to join
- 75 years old patients or more
- Diagnosis of AF
- Hospitalized in one of the 6 geriatrics unit participating in the study and / or whose clinical file is reviewed by the multidisciplinary team
Who cannot join
- opposition to data collection for research purposes
Trial locations and contacts
1 site in 1 country.
France1 site
Unité de gériatrie aiguë, hôpital Pitié-Salpêtrière (Pr Marc Verny)
Paris, 75013
About this study
Official title: Impact of Multidisciplinary Team Approach on the Utilization and Risks Related to Antithrombotic Drugs in Older Patients With Atrial Fibrillation
Antithrombotic drugs, which include antiplatelet and anticoagulant therapies, are used to prevent and treat many cardiovascular disorders. With the increase in prevalence of cardiovascular diseases and medical progress, these treatments are increasingly being prescribed, particularly in older patients. One of the main indications of antithrombotic drugs is atrial fibrillation (AF), a disease highly prevalent in older people, a population at high risk of adverse drug events. Notably, antithrombotic drugs are the first involved in serious adverse drug events, among which 40-70% may be preventable. In this context, six units of the hospital group "Assistance Publique - Hôpitaux de Paris" have created a multidisciplinary team which assesses antithrombotic prescriptions in older patients with AF. This team, gathering geriatricians, cardiologists, neurologists and haematologist specialized in haemostasis, evaluates the patient medical profile and suggests the most appropriate antithrombotic treatment based on their expertise and the available recommendations. Here we want to look at patients outcomes in light of the intervention of this multidisciplinary team.
Read the detailed description
The primary objective of this study is to evaluate the impact of the multidisciplinary team on the composite outcome of all-cause mortality, ischemic event or bleeding event at 3 months. Secondary objectives are to evaluate this composite outcome at 6 months and all-cause mortality, occurrence of ischemic event, occurrence of bleeding event, at 3 and 6 months.
- Conditions
- Atrial Fibrillation
- Being tested
- Standard of care, with intervention of the multidisciplinary team
- Keywords
- Atrial fibrillation, Frail Elderly, Anticoagulants, Platelet Aggregation Inhibitors, Multidisciplinary team
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of care, with intervention of the multidisciplinary teamOther
Patients with AF, aged of 75 years or more, with evaluation of their antithrombotic treatment by the multidisciplinary team. The review of patient's file by the multidisciplinary team is based on physician decision. These patients are hospitalized in one of the 6 geriatrics units participating in the study and / or are hospitalized in another ward but their clinical file is reviewed by the multidisciplinary team.
| Study group | Role | What they receive |
|---|---|---|
| experimental | Patients with AF, hospitalized in one of the 6 geriatrics units participating in the study, aged 75 years or over, without evaluation of their antithrombotic treatment by the multidisciplinary team. The lack of review of patient's file by the multidisciplinary team is based on physician decision. Receives: Other: Standard of care, with intervention of the multidisciplinary team | |
| Standard of care | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite outcome of all-cause mortality, ischemic event or bleeding event
All-cause mortality will be assess using patient's medical record or reported death by the referent general practitioner. Ischemic events include acute coronary syndrome, transient ischemic stroke or permanent ischemic stroke, arterial embolism, deep vein thrombosis and pulmonary embolism. Bleeding events include any bleeding event requiring a medical consult or a hospitalization
Measured: 3 months after inclusion
Secondary outcomes (7)
All-cause mortality
All-cause mortality will be assess using patient's medical record or reported death by the referent general practitioner.
Measured: 3 months after inclusion
Ischemic event
Ischemic events include acute coronary syndrome, transient ischemic stroke or permanent ischemic stroke, arterial embolism, deep vein thrombosis
Measured: 3 months after inclusion
Ischemic event
Ischemic events include acute coronary syndrome, transient ischemic stroke or permanent ischemic stroke, arterial embolism, deep vein thrombosis
Measured: 6 months after inclusion
Bleeding event
Bleeding events include any bleeding event requiring a medical consult or a hospitalization.
Measured: 3 months after inclusion
Bleeding event
Bleeding events include any bleeding event requiring a medical consult or a hospitalization.
Measured: 6 months after inclusion
Composite outcome of all-cause mortality, ischemic event or bleeding event
All-cause mortality will be assess by patient's medical record or reported death by the referent general practitioner. Ischemic events include transient ischemic attack or ischemic stroke, arterial embolism, deep vein thrombosis and pulmonary embolism. Bleeding events include any bleeding event requiring a medical consult or a hospitalization.
Measured: 6 months after inclusion
All-cause mortality
All-cause mortality will be assess by patient's medical record or reported death by the referent general practitioner.
Measured: 6 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2021
- Study start29 May 2021
- Primary completion5 Jul 2024
- Study completion5 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 833 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04932603
- Sponsor's protocol ID
- APHP210392
- Acronym
- ANTITHROMBOTEA
- Status last verified
- Jul 2025
- First submitted
- 14 Jun 2021
- Last updated
- 2 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Prunel M, Cochard A, Abbas L, Baudry E, Pautas E, Legris N, Assayag P, Frere C, Verny M, Simon-Tillaux N, Zerah L. Multidisciplinary team for antithrombotics management and clinical outcomes in older adults with atrial fibrillation: a target trial emulation. BMC Med. 2025 Sep 29;23(1):521. doi: 10.1186/s12916-025-04291-9.
PubMed 41024059
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Multidisciplinary Team Approach on the Utilization and Risks Related to Antithrombotic Drugs in Older Patients With Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT04932603
- Acronym / sponsor ID
- ANTITHROMBOTEA / APHP210392
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial fibrillation, Frail Elderly, Anticoagulants, Platelet Aggregation Inhibitors, Multidisciplinary team
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 833 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 29 May 2021 (actual)
- Primary completion
- 5 Jul 2024 (actual)
- Study completion
- 5 Jul 2024 (actual)
- First posted
- 21 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Antithrombotic drugs, which include antiplatelet and anticoagulant therapies, are used to prevent and treat many cardiovascular disorders. With the increase in prevalence of cardiovascular diseases and medical progress, these treatments are increasingly being prescribed, particularly in older patients. One of the main indications of antithrombotic drugs is atrial fibrillation (AF), a disease highly prevalent in older people, a population at high risk of adverse drug events. Notably, antithrombotic drugs are the first involved in serious adverse drug events, among which 40-70% may be preventable. In this context, six units of the hospital group "Assistance Publique - Hôpitaux de Paris" have created a multidisciplinary team which assesses antithrombotic prescriptions in older patients with AF. This team, gathering geriatricians, cardiologists, neurologists and haematologist specialized in haemostasis, evaluates the patient medical profile and suggests the most appropriate antithrombotic treatment based on their expertise and the available recommendations. Here we want to look at patients outcomes in light of the intervention of this multidisciplinary team.
Detailed description
The primary objective of this study is to evaluate the impact of the multidisciplinary team on the composite outcome of all-cause mortality, ischemic event or bleeding event at 3 months. Secondary objectives are to evaluate this composite outcome at 6 months and all-cause mortality, occurrence of ischemic event, occurrence of bleeding event, at 3 and 6 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental | – | Other: Standard of care, with intervention of the multidisciplinary teamPatients with AF, hospitalized in one of the 6 geriatrics units participating in the study, aged 75 years or over, without evaluation of their antithrombotic treatment by the multidisciplinary team. The lack of review of patient's file by the multidisciplinary team is based on physician decision. |
| Standard of care | – | – |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients hospitalized in 6 geriatrics units in the Greater Paris area and / or whose clinical file is reviewed by the multidisciplinary team PAtiet
Key inclusion criteria (3 listed)
- 75 years old patients or more
- Diagnosis of AF
- Hospitalized in one of the 6 geriatrics unit participating in the study and / or whose clinical file is reviewed by the multidisciplinary team
Key exclusion criteria (1 listed)
- opposition to data collection for research purposes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of care, with intervention of the multidisciplinary teamPatients with AF, aged of 75 years or more, with evaluation of their antithrombotic treatment by the multidisciplinary team. The review of patient's file by the multidisciplinary team is based on physician decision. These patients are hospitalized in one of the 6 geriatrics units participating in the study and / or are hospitalized in another ward but their clinical file is reviewed by the multidisciplinary team. | Other | experimental |
Primary outcome
Composite outcome of all-cause mortality, ischemic event or bleeding event
Time frame: 3 months after inclusion
All-cause mortality will be assess using patient's medical record or reported death by the referent general practitioner. Ischemic events include acute coronary syndrome, transient ischemic stroke or permanent ischemic stroke, arterial embolism, deep vein thrombosis and pulmonary embolism. Bleeding events include any bleeding event requiring a medical consult or a hospitalization
7 secondary outcomes
All-cause mortality
Time frame: 3 months after inclusion
Ischemic event
Time frame: 3 months after inclusion
Ischemic event
Time frame: 6 months after inclusion
Bleeding event
Time frame: 3 months after inclusion
Bleeding event
Time frame: 6 months after inclusion
Composite outcome of all-cause mortality, ischemic event or bleeding event
Time frame: 6 months after inclusion
All-cause mortality
Time frame: 6 months after inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
- Derived from this study: PubMed 41024059Prunel M, Cochard A, Abbas L, Baudry E, Pautas E, Legris N, Assayag P, Frere C, Verny M, Simon-Tillaux N, Zerah L. Multidisciplinary team for antithrombotics management and clinical outcomes in older adults with atrial fibrillation: a target trial emulation. BMC Med. 2025 Sep 29;23(1):521. doi: 10.1186/s12916-025-04291-9.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite outcome of all-cause mortality, ischemic event or bleeding event (time frame: 3 months after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04932603, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2025.