management of anticoagulant therapy monitored by an implantable device with telecardiology in patients with acute coronary syndrome associated with de novo atrial fibrillation arrhythmia

Conditions: Atrial Fibrillation, Myocardial Infarction

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

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.

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).

Keywords: acute coronary syndromes, atrial fibrillation, anticoagulant therapy, implantable device, telecardiology.