Management of Anticoagulant Therapy Monitored by an Implantable Device With Telecardiology in Patients With Acute Coronary Syndrome Associated With de Novo Atrial Fibrillation Arrhythmia
Condition(s) studied
Investigational drug(s) / intervention(s)
non-systematic prescription of anticoagulant therapy: the prescription of anticoagulant is managed by an implantable device follow up
Study 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
Eligibility
Primary outcome measure(s)
- Occurrence of hemorrhagic events — 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.
Trial sites (8)
| Facility | City | Region | Status |
|---|---|---|---|
| Centre Hospitalier d'Aix en Provence | Aix-en-Provence | France | |
| Centre hospitalier Chartres Louis Pasteur le Coudray | 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 | France | |
| Centre Hospitalier de Périgueux | Périgueux | France |
More Centre Hospitalier de PAU trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04276155 on ClinicalTrials.gov ↗ ← All trials in France