Multidisciplinary Team Approach to Prescribe Antithrombotic Therapy in Older People With Atrial Fibrillation

Recruiting

• Conditions: Atrial Fibrillation
• Interventions: Other: Standard of care, with intervention of the multidisciplinary team

• Registration Number: NCT04932603
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

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 Timeline

• Study Start: 2021-06-14
• Study First Submitted: 2021-06-14
• Study First Submitted QC: 2021-06-14
• Study First Posted: 2021-06-21
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-27
• Last Update Posted: 2023-10-30
• Primary Completion: 2024-08-14
• Study Completion: 2024-08-14

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 820

Inclusion Criteria

• 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

Exclusion Criteria

• opposition to data collection for research purposes

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
experimental	Standard of care, with intervention of the multidisciplinary team	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.

Primary Outcome Measures

Name	Time	Method
Composite outcome of all-cause mortality, ischemic event or bleeding event	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

Secondary Outcome Measures

Name	Time	Method
Bleeding event	6 months after inclusion	Bleeding events include any bleeding event requiring a medical consult or a hospitalization.
All-cause mortality	6 months after inclusion	All-cause mortality will be assess by patient's medical record or reported death by the referent general practitioner.
Ischemic event	6 months after inclusion	Ischemic events include acute coronary syndrome, transient ischemic stroke or permanent ischemic stroke, arterial embolism, deep vein thrombosis
Composite outcome of all-cause mortality, ischemic event or bleeding event	6 months after inclusion	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.

Trial Locations

Locations (1)

Unité de gériatrie aiguë, hôpital Pitié-Salpêtrière (Pr Marc Verny); 🇫🇷 Paris, France