NCT04932603

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
833

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 29, 2021

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

June 14, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 21, 2021

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 5, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 5, 2024

Completed
Last Updated

July 2, 2025

Status Verified

July 1, 2025

Enrollment Period

3.1 years

First QC Date

June 14, 2021

Last Update Submit

July 1, 2025

Conditions

Keywords

Atrial fibrillationFrail ElderlyAnticoagulantsPlatelet Aggregation InhibitorsMultidisciplinary team

Outcome Measures

Primary Outcomes (1)

  • 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

    3 months after inclusion

Secondary Outcomes (7)

  • All-cause mortality

    3 months after inclusion

  • Ischemic event

    3 months after inclusion

  • Ischemic event

    6 months after inclusion

  • Bleeding event

    3 months after inclusion

  • Bleeding event

    6 months after inclusion

  • +2 more secondary outcomes

Study Arms (2)

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.

Other: Standard of care, with intervention of the multidisciplinary team

Standard of care

Interventions

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.

experimental

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • 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

You may not qualify if:

  • opposition to data collection for research purposes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unité de gériatrie aiguë, hôpital Pitié-Salpêtrière (Pr Marc Verny)

Paris, 75013, France

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2021

First Posted

June 21, 2021

Study Start

May 29, 2021

Primary Completion

July 5, 2024

Study Completion

July 5, 2024

Last Updated

July 2, 2025

Record last verified: 2025-07

Locations