Management of Anticoagulant Therapy Monitored by an Implantable Device With Telecardiology in Patients With Acute Coronary Syndrome Associated With de Novo Atrial Fibrillation Arrhythmia

NCT ID: NCT04276155

Last Updated: 2024-02-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-22
• Study Completion Date: 2024-12-01

Brief Summary

Patients with Acute Coronary Syndrome associated with de novo atrial fibrillation are randomized to benefit from either a conventional therapy associating dual antiplatelet therapy (DAPT) and anticoagulant or DAPT and an implantable monitoring device with a follow-up by telecardiology

Detailed Description

Acute Coronary Syndrome associated with de novo atrial fibrillation is not uncommon. It worsens the short-term, medium-term and long-term prognosis. It is then usual, according to ESC recommendations, to add to the DAPT, an anticoagulant treatment, which is a source of iatrogenic events, in particular hemorrhagic events. However, recurrence is not a certainty. Albeit variable, its highest rate is estimated to be 38%. Consequently, a well-conducted screening of atrial fibrillation recurrence could allow to treat only selected recurrent patients. At present, this screening can be carried out in a reliable and minimally invasive way with an implantable device with telecardiology. We propose a study for these patients with ACS associated with de novo AF. The study will be multicenter, randomized, open-label, with two arms: patient conventionally treated (DAPT + AC) and patient treated by DAPT + implantable device and followed for two years by telecardiology. This patient will only reintegrate the first arm in case of AF recurrence.

Conditions

Atrial Fibrillation, Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Device

Acute Coranary Syndrome and de novo Atrial Fibrilation patients treated by DAPT only, in association with an implantable cardiac monitoring device and a follow-up by telecardiology. The anticoagulant treatment will only be administered to patients presenting a recurrence of Atrial Fibrilation

Group Type: EXPERIMENTAL

non-systematic prescription of anticoagulant therapy

Intervention Type: DRUG

the prescription of anticoagulant is managed by an implantable device follow up

Control

Acute Coranary Syndrome and de novo Atrial Fibrilation patients with standard management: DAPT in association with an anticoagulant treatment.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

non-systematic prescription of anticoagulant therapy

the prescription of anticoagulant is managed by an implantable device follow up

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Atrial fibrillation diagnosed before hospitalization for acute coronary syndrome, whether treated or not.
• Atrial fibrillation still present at inclusion time.
• Transient atrial fibrillation due to a reversible disorder (thyrotoxycosis, pulmonary embolism, recent surgery).
• Acute coronary syndrome that has not been revascularized.
• Acute coronary syndrome surgically treated (bypass).
• Patient already on anticoagulant therapy.
• Scheduled aortocoronary bypass.
• Creatinine clearance < 30 ml per minute.

Exclusion Criteria

Pathologic criteria :

• Atrial fibrillation diagnosed before hospitalization for acute coronary syndrome, whether treated or not.
• Atrial fibrillation still present at inclusion time.
• Transient atrial fibrillation due to a reversible disorder (thyrotoxycosis, pulmonary embolism, recent surgery).
• Acute coronary syndrome that has not been revascularized.
• Acute coronary syndrome surgically treated (bypass).
• Patient already on anticoagulant therapy.
• Scheduled aortocoronary bypass.
• Creatinine clearance < 30 ml per minute.

Bleeding risks :

• Contraindications to anticoagulant therapy.
• Active internal hemorrhage, clinically significant bleeding, bleeding non accessible to compression or bleeding diathesis within 30 days prior to selection visit.
• Platelet count < 90000/µL at the selection visit.
• Bleeding event in the twelve months prior to inclusion.
• Bleeding events detected either clinically or biologically (hemoglobinemia < 10g/dl).
• Elective surgery.

Comorbidities :

• Cardiogenic shock.
• Hyperthyroidism.
• Prior history of significant liver disease (acute hepatitis, active chronic hepatitis, cirrhosis) or liver function disorder detected at selection visit.
• Significant mitral valvular heart disease.

General :

• Patient under 18.
• Non menopausal woman or without contraception.
• Patient whose physical and / or mental health may have an impact on the compliance to the study.
• Participation in another biomedical research study (interventional or noninterventional) or participation in a research study within the 30 days prior to inclusion.
• Protected adults (under judicial protection, guardianship, or supervision).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier de PAU

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre Hospitalier d'Aix en Provence

Aix-en-Provence, , France

Site Status: RECRUITING

Centre hospitalier Chartres Louis Pasteur le Coudray

Chartres, , France

Site Status: RECRUITING

Centre Hospitalier d'Haguenau

Haguenau, , France

Site Status: RECRUITING

Centre Hospitalier de La Rochelle

La Rochelle, , France

Site Status: RECRUITING

Centre Hospitalier de Libournes

Libourne, , France

Site Status: RECRUITING

Centre Hospitalier d'Annecy Genevois

Metz-Tessy, , France

Site Status: RECRUITING

Centre hospitalier de Pau

Pau, , France

Site Status: RECRUITING

Centre Hospitalier de Périgueux

Périgueux, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Alice Séris

Role: CONTACT

alice.seris@ch-pau.fr

05 59 72 69 97

Facility Contacts

Bernard JOUVE

Role: primary

Franck ALBERT

Role: primary

Fabien DEPOLI

Role: primary

Antoine MILHEM

Role: primary

Pierre CHEVALLEREAU

Role: primary

Antoine DOMPNIER

Role: primary

Centre h de Pau

Role: primary

serisa01@ch-pau.fr

0559726997

Jean LITALIEN

Role: primary

Other Identifiers

CHPAU2020/01

Identifier Type: -

Identifier Source: org_study_id