Status:
RECRUITING
Management of Anticoagulant Therapy Monitored by an Implantable Device With Telecardiology in Patients With Acute Coronary Syndrome Associated With de Novo Atrial Fibrillation Arrhythmia
Lead Sponsor:
Centre Hospitalier de PAU
Conditions:
Atrial Fibrillation, Myocardial Infarction
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 anticoag...
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,...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
February 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT04276155
Start Date
February 22 2021
End Date
December 1 2024
Last Update
February 7 2024
Active Locations (8)
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1
Centre Hospitalier d'Aix en Provence
Aix-en-Provence, France
2
Centre hospitalier Chartres Louis Pasteur le Coudray
Chartres, France
3
Centre Hospitalier d'Haguenau
Haguenau, France
4
Centre Hospitalier de La Rochelle
La Rochelle, France