Atrial Fibrillation, Myocardial InfarctionPhase 4SCA FANCT04276155
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 Phase 4 study testing non-systematic prescription of anticoagulant therapy in people with Atrial Fibrillation, Myocardial Infarction, run by Centre Hospitalier de PAU at 8 sites in France.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Myocardial Infarction
- What is being tested?
- non-systematic prescription of anticoagulant therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 8 sitesFrance
- Study dates
- 3 Aug 2021to 22 Jun 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 27Show fewer
- 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).
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
France8 sites
Centre Hospitalier d'Aix en Provence
Aix-en-Provence
Centre hospitalier Chartres Louis Pasteur le Coudray
Chartres
Centre Hospitalier d'Haguenau
Haguenau
Centre Hospitalier de La Rochelle
La Rochelle
Centre Hospitalier de Libournes
Libourne
Centre Hospitalier d'Annecy Genevois
Metz-Tessy
Centre hospitalier de Pau
Pau, 64046
Centre Hospitalier de Périgueux
Périgueux
About this study
Official title: 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
Read the 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.
- Being tested
- non-systematic prescription of anticoagulant therapy
- Keywords
- Acute Coronary Syndromes, Atrial Fibrillation, Anticoagulant therapy, Implantable device, Telecardiology.
- Medical subject headings
- Atrial Fibrillation, Myocardial Infarction, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-systematic prescription of anticoagulant therapyDrug
the prescription of anticoagulant is managed by an implantable device follow up
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2020
- Study start3 Aug 2021
- Primary completion22 Jun 2027 (estimated)
- Study completion22 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation, Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective trial of therapeutic strategy, interventional, randomized and open-label, national and multicenter
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de PAU
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04276155
- Sponsor's protocol ID
- CHPAU2020/01
- Acronym
- SCA FA
- Status last verified
- Mar 2026
- First submitted
- 18 Feb 2020
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04276155
- Acronym / sponsor ID
- SCA FA / CHPAU2020/01
- Keywords
- Acute Coronary Syndromes, Atrial Fibrillation, Anticoagulant therapy, Implantable device, Telecardiology.
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Centre Hospitalier de PAUUniversity, hospital or other
- Study start
- 3 Aug 2021 (actual)
- Primary completion
- 22 Jun 2027 (estimated)
- Study completion
- 22 Jun 2027 (estimated)
- First posted
- 19 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- prospective trial of therapeutic strategy, interventional, randomized and open-label, national and multicenter
| Arm | Type | Receives |
|---|---|---|
| Device | Experimental | Drug: non-systematic prescription of anticoagulant therapyAcute 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 |
| Control | No intervention | –Acute Coranary Syndrome and de novo Atrial Fibrilation patients with standard management: DAPT in association with an anticoagulant treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (27 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| non-systematic prescription of anticoagulant therapythe prescription of anticoagulant is managed by an implantable device follow up | Drug | Device |
Primary outcome
Occurrence of hemorrhagic events
Time frame: 2 years
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing non-systematic prescription of anticoagulant therapy in people with Atrial Fibrillation, Myocardial Infarction, run by Centre Hospitalier de PAU at 8 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of hemorrhagic events (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.