Informations générales (source: ClinicalTrials.gov)
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 (SCA FA)
Interventional
Phase 4
Centre Hospitalier de PAU (Voir sur ClinicalTrials)
février 2021
décembre 2024
29 juin 2024
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
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Centre Hospitalier d'Annecy Genevois - Metz-Tessy - France | Antoine DOMPNIER | Contact (sur clinicalTrials) | |||
| Centre Hospitalier de La Rochelle - La Rochelle - France | Antoine MILHEM | Contact (sur clinicalTrials) | |||
| Centre Hospitalier de Libournes - Libourne - France | Pierre CHEVALLEREAU | Contact (sur clinicalTrials) | |||
| Centre Hospitalier de Périgueux - Périgueux - France | Jean LITALIEN | Contact (sur clinicalTrials) | |||
| Centre Hospitalier d'Haguenau - Haguenau - France | Fabien DEPOLI | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre hospitalier Chartres Louis Pasteur le Coudray - Chartres - France | Franck ALBERT | Contact (sur clinicalTrials) | |||
| Centre Hospitalier d'Aix en Provence - Aix en Provence - France | Bernard JOUVE | Contact (sur clinicalTrials) | |||
| Centre hospitalier de Pau - 64046 - Pau - France | Centre h de Pau | Contact (sur clinicalTrials) | |||
Critères
Tous
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.
- 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.
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).