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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Device | Experimental | 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 |
|
| Control | No Intervention | Acute Coranary Syndrome and de novo Atrial Fibrilation patients with standard management: DAPT in association with an anticoagulant treatment. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| non-systematic prescription of anticoagulant therapy | Drug | the prescription of anticoagulant is managed by an implantable device follow up |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of hemorrhagic events | To show that the introduction of an anticoagulant treatment in patients with ACS and de novo AF based on the data furnished by an implantable holter with remote monitoring is safer in terms of occurrence of hemorrhagic events than the systematic introduction of an anticoagulant treatment associated to DAPT based on the CHA2DS2-VASc score. CHA2DS2-Vasc score, derived from CHADS2 score. It assesses the risk of a person with atrial fibrillation (AF) without associated valve pathology, to experience an ischemic stroke, in other words, to assess the need for anticoagulant treatment. It ranges from 0 to 10. A score of 0 is considered a low risk. A score greater than or equal to 2 is considered a significant risk of embolic complication and should lead to discussion of the introduction of oral anticoagulant therapy. | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
Pathologic criteria :
Bleeding risks :
Comorbidities :
General :
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier d'Aix en Provence | Aix-en-Provence | France | ||||
| Centre hospitalier Chartres Louis Pasteur le Coudray |
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prospective trial of therapeutic strategy, interventional, randomized and open-label, national and multicenter
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| Chartres |
| France |
| Centre Hospitalier d'Haguenau | Haguenau | France |
| Centre Hospitalier de La Rochelle | La Rochelle | France |
| Centre Hospitalier de Libournes | Libourne | France |
| Centre Hospitalier d'Annecy Genevois | Metz-Tessy | France |
| Centre hospitalier de Pau | Pau | 64046 | France |
| Centre Hospitalier de Périgueux | Périgueux | France |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D009203 | Myocardial Infarction |
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017202 | Myocardial Ischemia |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D009336 | Necrosis |
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