Clinical trial NCT04276155: Management of Anticoagulant Therapy Monitored by an Implantable Device With Telecardiology in Patients With Acute Coronary Syndrome Associated With de Novo Atrial Fibrillation Arrhythmia
Official title: Management of Anticoagulant Therapy Monitored by an Implantable Device With Telecardiology in Patients With Acute Coronary Syndrome Associated With de Novo Atrial Fibrillation Arrhythmia: A Prospective Multicenter Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Atrial Fibrillation, Myocardial Infarction
Keywords: Acute Coronary Syndromes, Atrial Fibrillation, Anticoagulant therapy, Implantable device, Telecardiology.
Lead sponsor: Centre Hospitalier de PAU
Sponsor class: OTHER
First posted: 2020-02-19
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective trial of therapeutic strategy, interventional, randomized and open-label, national and multicenter
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Occurrence of hemorrhagic events
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Aix en Provence
country: France
facility: Centre Hospitalier d'Aix en Provence
city: Chartres
country: France
facility: Centre hospitalier Chartres Louis Pasteur le Coudray
city: Haguenau
country: France
facility: Centre Hospitalier d'Haguenau
city: La Rochelle
country: France
facility: Centre Hospitalier de La Rochelle
city: Libourne
country: France
facility: Centre Hospitalier de Libournes
city: Metz-Tessy
country: France
facility: Centre Hospitalier d'Annecy Genevois
city: Pau
country: France
facility: Centre hospitalier de Pau
city: Périgueux
country: France
facility: Centre Hospitalier de Périgueux
Study officials:
References: