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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

Full criteria on ClinicalTrials.gov

Sites (15)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Centre Hospitalier Henri Mondor
Coordinator of this site? Confirm its status
AurillacFranceActive, not recruiting
Centre Hospitalier de Haguenau
Coordinator of this site? Confirm its status
HaguenauFranceActive, not recruiting
Centre Hospitalier Groupe Hospitalier De La Rochelle Re Aunis
Coordinator of this site? Confirm its status
La RochelleFranceActive, not recruiting
Les Hopitaux De Chartres
Coordinator of this site? Confirm its status
Le CoudrayFranceActive, not recruiting
Centre Hospitalier De Libourne Robert Boulin
Coordinator of this site? Confirm its status
Libourne CedexFranceActive, not recruiting
Centre Hospitalier Universitaire De Montpellier
Coordinator of this site? Confirm its status
Montpellier Cedex 5FranceActive, not recruiting
Centre Hospitalier Universitaire De Nimes
Coordinator of this site? Confirm its status
Nimes Cedex 9FranceActive, not recruiting
Hopital Européen George Pompidou
Coordinator of this site? Confirm its status
ParisFranceActive, not recruiting
Hopitaux Universitaires Pitie Salpetriere
Coordinator of this site? Confirm its status
Paris Cedex 13FranceActive, not recruiting
Centre Hospitalier De Pau
Coordinator of this site? Confirm its status
Pau CedexFranceActive, not recruiting
Centre Hospitalier de Perigueux
Coordinator of this site? Confirm its status
PérigueuxFranceActive, not recruiting
Centre Hospitalier Annecy Genevois
Coordinator of this site? Confirm its status
Pringy CedexFranceActive, not recruiting
Les Hopitaux Universitaires De Strasbourg
Coordinator of this site? Confirm its status
Strasbourg CedexFranceActive, not recruiting
Clinique Pasteur
Coordinator of this site? Confirm its status
Toulouse Cedex 3FranceActive, not recruiting
Centre Hospitalier Intercommunal de Villeneuve Saint Georges
Coordinator of this site? Confirm its status
Villeneuve-Saint-GeorgesFranceActive, not recruiting

This page is information, not medical advice. Discuss any trial with your doctor.