Managing anticoagulant therapy with an implantable device for patients with acute coronary syndrome and atrial fibrillation

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

This study is testing if an implantable device can help manage blood-thinning treatment for patients with acute coronary syndrome and new-onset atrial fibrillation better than standard care.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 500 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Centre Hospitalier de PAU (Academic / other)
• Locations: 8 sites (Aix en Provence and 7 other locations)
• Trial ID: NCT04276155 on ClinicalTrials.gov

What this trial studies

This study investigates the management of anticoagulant therapy in patients experiencing acute coronary syndrome associated with new-onset atrial fibrillation. Participants will be randomized to receive either standard treatment with dual antiplatelet therapy and anticoagulants or a combination of dual antiplatelet therapy and an implantable monitoring device, with follow-up via telecardiology. The goal is to assess whether the implantable device can effectively monitor atrial fibrillation recurrence and reduce unnecessary anticoagulant use. The study will be multicenter, randomized, and open-label, with a follow-up period of two years.

Who should consider this trial

Good fit: Ideal candidates include patients diagnosed with atrial fibrillation prior to hospitalization for acute coronary syndrome who are still experiencing atrial fibrillation at the time of inclusion.

Not a fit: Patients with transient atrial fibrillation due to reversible disorders or those already on anticoagulant therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more personalized and safer anticoagulant therapy for patients with acute coronary syndrome and atrial fibrillation.

How similar studies have performed: While similar approaches using implantable devices for monitoring have shown promise, this specific combination of interventions is relatively novel.

Eligibility criteria

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).

Where this trial is running

Aix en Provence and 7 other locations

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

Study contacts

• Study coordinator: Alice Séris

Conditions Atrial Fibrillation, Myocardial Infarction; Acute Coronary Syndromes, Atrial Fibrillation, Anticoagulant therapy, Implantable device, Telecardiology.