Management of Anticoagulant Therapy Monitored by an Implantable Device With Telecardiology in Pat… (NCT04276155) | Clinical Trial Compass
Active — Not RecruitingPhase 4
Management of Anticoagulant Therapy Monitored by an Implantable Device With Telecardiology in Patients With Acute Coronary Syndrome Associated With de Novo Atrial Fibrillation Arrhythmia
France500 participantsStarted 2021-08-03
Plain-language 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
Who can participate
Age range18 Years
SexALL
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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 (h…