NCT04276155Active, not recruitingPhase 4
Management of Anticoagulant Therapy Monitored by an Implantable Device With Telecardiology in Patients With Acute Coronary Syndrome Associated With de Novo Atrial Fibrillation Arrhythmia
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
Source: ClinicalTrials.gov · Last updated 23 Mar 2026
Brief summary (registry, in English)
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 (registry)
- Active, not recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 500 (estimated)
- First submitted
- 18 Feb 2020
- Start date
- 3 Aug 2021
- Primary completion date
- 22 Jun 2027
- Lead sponsor
- Centre Hospitalier de PAU
- NCT number
- NCT04276155
- EU CT number
- 2024-515433-15-02
- EudraCT number
- 2020-000721-11
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 500
- From 3 Aug 2021 to the primary completion date, 22 Jun 2027
- 15 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patient already on anticoagulant therapy.
- 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.
- Bleeding event in the twelve months prior to inclusion.
- Elective surgery.
- Comorbidities :
- Prior history of significant liver disease (acute hepatitis, active chronic hepatitis, cirrhosis) or liver function disorder detected at selection visit.
- Participation in another biomedical research study (interventional or noninterventional) or participation in a research study within the 30 days prior to inclusion.
Other illness
- Atrial fibrillation diagnosed before hospitalization for acute coronary syndrome, whether treated or not.
- 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).
- Bleeding events detected either clinically or biologically (hemoglobinemia \< 10g/dl).
- Significant mitral valvular heart disease.
- General :
Lab values
- Creatinine clearance \< 30 ml per minute.
- Bleeding risks :
- Platelet count \< 90000/µL at the selection visit.
Other
- Pathologic criteria :
- Atrial fibrillation still present at inclusion time.
- Scheduled aortocoronary bypass.
- Cardiogenic shock.
- Hyperthyroidism.
- 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.
- Protected adults (under judicial protection, guardianship, or supervision).
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (15)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre Hospitalier Henri Mondor Coordinator of this site? Confirm its status | Aurillac | France | Active, not recruiting |
| Centre Hospitalier de Haguenau Coordinator of this site? Confirm its status | Haguenau | France | Active, not recruiting |
| Centre Hospitalier Groupe Hospitalier De La Rochelle Re Aunis Coordinator of this site? Confirm its status | La Rochelle | France | Active, not recruiting |
| Les Hopitaux De Chartres Coordinator of this site? Confirm its status | Le Coudray | France | Active, not recruiting |
| Centre Hospitalier De Libourne Robert Boulin Coordinator of this site? Confirm its status | Libourne Cedex | France | Active, not recruiting |
| Centre Hospitalier Universitaire De Montpellier Coordinator of this site? Confirm its status | Montpellier Cedex 5 | France | Active, not recruiting |
| Centre Hospitalier Universitaire De Nimes Coordinator of this site? Confirm its status | Nimes Cedex 9 | France | Active, not recruiting |
| Hopital Européen George Pompidou Coordinator of this site? Confirm its status | Paris | France | Active, not recruiting |
| Hopitaux Universitaires Pitie Salpetriere Coordinator of this site? Confirm its status | Paris Cedex 13 | France | Active, not recruiting |
| Centre Hospitalier De Pau Coordinator of this site? Confirm its status | Pau Cedex | France | Active, not recruiting |
| Centre Hospitalier de Perigueux Coordinator of this site? Confirm its status | Périgueux | France | Active, not recruiting |
| Centre Hospitalier Annecy Genevois Coordinator of this site? Confirm its status | Pringy Cedex | France | Active, not recruiting |
| Les Hopitaux Universitaires De Strasbourg Coordinator of this site? Confirm its status | Strasbourg Cedex | France | Active, not recruiting |
| Clinique Pasteur Coordinator of this site? Confirm its status | Toulouse Cedex 3 | France | Active, not recruiting |
| Centre Hospitalier Intercommunal de Villeneuve Saint Georges Coordinator of this site? Confirm its status | Villeneuve-Saint-Georges | France | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.