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
Overview
- Phase
- Phase 4
- Intervention
- non-systematic prescription of anticoagulant therapy
- Conditions
- Atrial Fibrillation, Myocardial Infarction
- Sponsor
- Centre Hospitalier de PAU
- Enrollment
- 500
- Locations
- 8
- Primary Endpoint
- Occurrence of hemorrhagic events
- Status
- Active, not recruiting
- Last Updated
- last month
Overview
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.
Investigators
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 :
Arms & Interventions
Device
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
Intervention: non-systematic prescription of anticoagulant therapy
Outcomes
Primary Outcomes
Occurrence of hemorrhagic events
Time Frame: 2 years
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.