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

NCT04276155 | Active Not Recruiting Phase 4

• 1 other identifier: CHPAU2020/01
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 8

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

Conditions

Atrial Fibrillation, Myocardial Infarction

Keywords

Acute Coronary Syndromes, Atrial Fibrillation, Anticoagulant therapy, Implantable device, Telecardiology.

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Device

EXPERIMENTAL

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

Control

NO INTERVENTION

Acute Coranary Syndrome and de novo Atrial Fibrilation patients with standard management: DAPT in association with an anticoagulant treatment.

Interventions

non-systematic prescription of anticoagulant therapy DRUG

the prescription of anticoagulant is managed by an implantable device follow up

Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• Patient already on anticoagulant therapy.
• Scheduled aortocoronary bypass.
• Creatinine clearance \< 30 ml per minute.

You may not qualify if:

• Pathologic criteria :
• 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).
• 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 events detected either clinically or biologically (hemoglobinemia \< 10g/dl).
• Elective surgery.
• Comorbidities :

Sponsors & Collaborators

• Centre Hospitalier de PAU: lead

Study Sites (8)

Centre Hospitalier d'Aix en Provence

Aix-en-Provence, France

Location

Centre hospitalier Chartres Louis Pasteur le Coudray

Chartres, France

Location

Centre Hospitalier d'Haguenau

Haguenau, France

Location

Centre Hospitalier de La Rochelle

La Rochelle, France

Location

Centre Hospitalier de Libournes

Libourne, France

Location

Centre Hospitalier d'Annecy Genevois

Metz-Tessy, France

Location

Centre hospitalier de Pau

Pau, 64046, France

Location

Centre Hospitalier de Périgueux

Périgueux, France

Location

MeSH Terms

Conditions

Atrial Fibrillation; Myocardial Infarction; Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Myocardial Ischemia; Vascular Diseases; Infarction; Ischemia; Necrosis

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: prospective trial of therapeutic strategy, interventional, randomized and open-label, national and multicenter

Study Record Dates

• First Submitted: February 18, 2020
• First Posted: February 19, 2020
• Study Start: August 3, 2021
• Primary Completion (Estimated): June 22, 2027
• Study Completion (Estimated): June 22, 2027
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (8)