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

Atrial Fibrillation Clinical Trial

— ANTITHROMBOTEA  

Official title:

Impact of Multidisciplinary Team Approach on the Utilization and Risks Related to Antithrombotic Drugs in Older Patients With Atrial Fibrillation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04932603
• Other study ID #: APHP210392
• Status: Recruiting
• Start date: June 14, 2021
• Est. completion date: August 14, 2024

Study information

• Verified date: October 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Lorène Zerah, MD, PhD
• Phone: 01 42 16 03 36
• Email: lorene.zerah[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 820
• Est. completion date: August 14, 2024
• Est. primary completion date: August 14, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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

Locations

Country	Name	City	State
France	Unité de gériatrie aiguë, hôpital Pitié-Salpêtrière (Pr Marc Verny)	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	All-cause mortality	All-cause mortality will be assess using patient's medical record or reported death by the referent general practitioner.	3 months after inclusion
Secondary	Ischemic event	Ischemic events include acute coronary syndrome, transient ischemic stroke or permanent ischemic stroke, arterial embolism, deep vein thrombosis	3 months after inclusion
Secondary	Ischemic event	Ischemic events include acute coronary syndrome, transient ischemic stroke or permanent ischemic stroke, arterial embolism, deep vein thrombosis	6 months after inclusion
Secondary	Bleeding event	Bleeding events include any bleeding event requiring a medical consult or a hospitalization.	3 months after inclusion
Secondary	Bleeding event	Bleeding events include any bleeding event requiring a medical consult or a hospitalization.	6 months after inclusion
Secondary	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.	6 months after inclusion
Secondary	All-cause mortality	All-cause mortality will be assess by patient's medical record or reported death by the referent general practitioner.	6 months after inclusion