Heart monitor could make blood thinners safer for heart attack patients
NCT ID NCT04276155
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether an implantable heart monitor with remote follow-up can help doctors decide when to prescribe blood thinners to patients who have had a heart attack and developed new atrial fibrillation. The goal is to reduce bleeding complications compared to the standard approach of giving blood thinners based on a risk score. About 500 participants will be randomly assigned to either standard care or the implantable monitor strategy.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- implantable heart monitor with remote follow-up
- What this could lead to
- If successful, this could lead to a safer way to decide when to use blood thinners in heart attack patients with atrial fibrillation, reducing bleeding risks.
- What could go wrong
- This is a Phase 4 study, so the approach is already in use, but it may not prove safer than standard care. The implant device itself carries small risks like infection or malfunction.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 500 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2021
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Centre Hospitalier d'Aix en Provence
Aix-en-Provence, France
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Centre Hospitalier d'Annecy Genevois
Metz-Tessy, France
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Centre Hospitalier d'Haguenau
Haguenau, France
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Centre Hospitalier de La Rochelle
La Rochelle, France
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Centre Hospitalier de Libournes
Libourne, France
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Centre Hospitalier de Périgueux
Périgueux, France
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Centre hospitalier Chartres Louis Pasteur le Coudray
Chartres, France
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Centre hospitalier de Pau
Pau, 64046, France