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

Centre Hospitalier de PAU

Status and phase: Enrolling; Phase 4

Conditions: Atrial Fibrillation, Myocardial Infarction

Treatments: Drug: non-systematic prescription of anticoagulant therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04276155

CHPAU2020/01

Details and patient eligibility

About

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

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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500 participants in 2 patient groups

Device

Experimental group

Description:

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

Treatment:

Drug: non-systematic prescription of anticoagulant therapy

Control

No Intervention group

Description:

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