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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Atrial Fibrillation, Myocardial Infarction
• Intervention / Treatment: Drug: non-systematic prescription of anticoagulant therapy

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, 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.

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Aix-en-Provence, France
    • Centre Hospitalier d'Aix en Provence
  • Chartres, France
    • Centre hospitalier Chartres Louis Pasteur le Coudray
  • Haguenau, France
    • Centre Hospitalier d'Haguenau
  • La Rochelle, France
    • Centre Hospitalier de La Rochelle
  • Libourne, France
    • Centre Hospitalier de Libournes
  • Metz-Tessy, France
    • Centre Hospitalier D'Annecy Genevois
  • Pau, France, 64046
    • Centre Hospitalier de Pau
  • Périgueux, France
    • Centre Hospitalier de Perigueux

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Device; Acute Coranary Syndrome and de novo Atrial Fibrilation patients treated by DAPT only, in association with an implantable cardiac monitoring device and a follow-up by telecardiology. The anticoagulant treatment will only be administered to patients presenting a recurrence of Atrial Fibrilation	Drug: non-systematic prescription of anticoagulant therapy; the prescription of anticoagulant is managed by an implantable device follow up
No Intervention: Control; Acute Coranary Syndrome and de novo Atrial Fibrilation patients with standard management: DAPT in association with an anticoagulant treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier de PAU

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2021
• Primary Completion (Estimated): June 22, 2027
• Study Completion (Estimated): June 22, 2027

Study Registration Dates

• First Submitted: February 18, 2020
• First Submitted That Met QC Criteria: February 18, 2020
• First Posted (Actual): February 19, 2020

Study Record Updates

• Last Update Posted (Actual): March 23, 2026
• Last Update Submitted That Met QC Criteria: March 19, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Acute Coronary Syndromes, Atrial Fibrillation, Anticoagulant therapy, Implantable device, Telecardiology.
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Infarction; Necrosis; Myocardial Ischemia; Ischemia; Pathological Conditions, Signs and Symptoms; Atrial Fibrillation; Myocardial Infarction; Acute Coronary Syndrome; Anticoagulants
• Other Study ID Numbers: CHPAU2020/01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No