A Phase 4 interventional study of non-systematic prescription of anticoagulant therapy in Atrial Fibrillation, Myocardial Infarction, sponsored by Centre Hospitalier de PAU. Active, not recruiting at 8 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-23.
Sponsored by Centre Hospitalier de PAU · Phase 4, Interventional, and Treatment
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.
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's planned enrollment of 500 is above the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.
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Exclusion Criteria:
Pathologic criteria :
Bleeding risks :
Comorbidities :
General :
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
Drug: non-systematic prescription of anticoagulant therapy
Acute Coranary Syndrome and de novo Atrial Fibrilation patients with standard management: DAPT in association with an anticoagulant treatment.
the prescription of anticoagulant is managed by an implantable device follow up
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.
Time frame: 2 years
Plan to share: No
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This study is active, not recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier de PAU