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

• Status: Recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Hospitalier de PAU
• Treatments: Anticoagulants

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).