Management of Anticoagulant Therapy Monitored by an Implantable Device With Telecardiology in Patients With Acute Coronary Syndrome Associated With de Novo Atrial Fibrillation Arrhythmia

Last updated: February 6, 2024
Sponsor: Centre Hospitalier de PAU
Overall Status: Active - Recruiting

Phase

4

Condition

Circulation Disorders

Dysrhythmia

Hypercholesterolemia

Treatment

non-systematic prescription of anticoagulant therapy

Clinical Study ID

NCT04276155
CHPAU2020/01
  • Ages > 18
  • All Genders

Study 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 anticoagulant or DAPT and an implantable monitoring device with a follow-up by telecardiology

Eligibility Criteria

Inclusion

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, pulmonaryembolism, 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

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, pulmonaryembolism, 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 accessibleto 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 tothe study.
  • Participation in another biomedical research study (interventional ornoninterventional) or participation in a research study within the 30 days prior toinclusion.
  • Protected adults (under judicial protection, guardianship, or supervision).

Study Design

Total Participants: 500
Treatment Group(s): 1
Primary Treatment: non-systematic prescription of anticoagulant therapy
Phase: 4
Study Start date:
February 22, 2021
Estimated Completion Date:
December 01, 2024

Study 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, to add to the DAPT, an anticoagulant treatment, which is a source of iatrogenic events, in particular hemorrhagic events. However, recurrence is not a certainty. Albeit variable, its highest rate is estimated to be 38%. Consequently, a well-conducted screening of atrial fibrillation recurrence could allow to treat only selected recurrent patients. At present, this screening can be carried out in a reliable and minimally invasive way with an implantable device with telecardiology. We propose a study for these patients with ACS associated with de novo AF. The study will be multicenter, randomized, open-label, with two arms: patient conventionally treated (DAPT + AC) and patient treated by DAPT + implantable device and followed for two years by telecardiology. This patient will only reintegrate the first arm in case of AF recurrence.

Connect with a study center

  • Centre Hospitalier d'Aix en Provence

    Aix en Provence,
    France

    Active - Recruiting

  • Centre hospitalier Chartres Louis Pasteur le Coudray

    Chartres,
    France

    Active - Recruiting

  • Centre Hospitalier d'Haguenau

    Haguenau,
    France

    Active - Recruiting

  • Centre Hospitalier de La Rochelle

    La Rochelle,
    France

    Active - Recruiting

  • Centre Hospitalier de Libournes

    Libourne,
    France

    Active - Recruiting

  • Centre Hospitalier d'Annecy Genevois

    Metz-Tessy,
    France

    Active - Recruiting

  • Centre hospitalier de Pau

    Pau, 64046
    France

    Active - Recruiting

  • Centre Hospitalier de Périgueux

    Périgueux,
    France

    Active - Recruiting

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