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Heart monitor could make blood thinners safer for heart attack patients

NCT ID NCT04276155

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 500 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2021

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

  • Centre Hospitalier d'Aix en Provence

    Aix-en-Provence, France

  • Centre Hospitalier d'Annecy Genevois

    Metz-Tessy, France

  • Centre Hospitalier d'Haguenau

    Haguenau, France

  • Centre Hospitalier de La Rochelle

    La Rochelle, France

  • Centre Hospitalier de Libournes

    Libourne, France

  • Centre Hospitalier de Périgueux

    Périgueux, France

  • Centre hospitalier Chartres Louis Pasteur le Coudray

    Chartres, France

  • Centre hospitalier de Pau

    Pau, 64046, France