Atrial Fibrillation, Myocardial Infarction Clinical Trial
— SCA FAOfficial title:
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
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
| Status | Recruiting |
| Enrollment | 500 |
| Est. completion date | December 1, 2024 |
| Est. primary completion date | December 1, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 : - 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). |
| Country | Name | City | State |
|---|---|---|---|
| France | 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Centre Hospitalier de PAU |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 |