Acute Coronary Syndromes (ACS)EDUSCANCT07178444
Evaluation of the Effectiveness of an Interdisciplinary Intervention After Acute Coronary Syndrome on Low-Density Lipoprotein Cholesterol Levels
A study testing "New" care pathway and "Standard" care pathway in people with Acute Coronary Syndromes (ACS) and Acute Coronary Syndromes, run by Assistance Publique - Hôpitaux de Paris at 4 sites in France.
Trial summary
According to the World Health Organization (WHO), cardiovascular diseases are the worldwide leading cause of death. For the French public health, cardiovascular diseases are the leading cause of death for the women and the second for men. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndromes (ACS), Acute Coronary Syndromes
- What is being tested?
- "New" care pathway and "Standard" care pathway
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 4 sitesFrance
- Study dates
- Nov 2025to Nov 2028
- Phase
- Interventional
- 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
- Adult patients hospitalized for ACS (ST+ or ST-), affiliated with a social security scheme, able to understand the protocol and having signed the study consent.
Who cannot join
- Patients with a complication of the ACS (mechanical complication, cardiogenic shock, very severe left ventricular dysfunction, presence of an intraventricular thrombus, complex ventricular rhythm disorder) ;
- Proven cognitive impairment or decompensated psychological/psychiatric disorder ;
- Any progressive inflammatory and/or infectious condition ;
- Any orthopedic problem precluding the physical activity ;
- Current participation in any clinical research project aimed at reducing LDL cholesterol levels ;
- Pregnant or breastfeeding woman ;
- Patient receiving state medical assistance ;
- Patient under guardianship or curatorship, or any other legal protection measure ;
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France4 sites
Centre Hospitalier Sud Francilien, Pôle Cardiologie
Corbeil-Essonnes, 91100
Müge TABAN, 0033(0)161693701, muge.taban@chsf.fr
Hopital Saint Joseph-Saint Luc, Cardiologie
Lyon, 69007
Bochra RIAHI, 0033(4)78618682, briahi@saintjosephsaintluc.fr
CHU Montpellier - Hôpital Arnaud de Villeneuve, Cardiologie
Montpellier, 34295
Nawel AOUNI, 033(4)67333203, n-aouni@chu-montpellier.fr
Hôpital Européen Georges Pompidou - AP-HP, Cardiologie
Paris, 74015
Mélissa JOLY GOURJAULT, 0033(0)156093001, melissa.gourjault@aphp.fr
About this study
According to the World Health Organization (WHO), cardiovascular diseases are the worldwide leading cause of death. For the French public health, cardiovascular diseases are the leading cause of death for the women and the second for men. Each year in France, approximately 120,000 acute coronary syndromes (ACS) occur, including 60,000 myocardial infarctions and more than 15,000 deaths. To prevent or reverse this process, the WHO recommends early detection of the diseases and reduce behavioral and cardiovascular risk factors.
For the patient, the European Society of Cardiology (ESC) recommends the implementation of secondary prevention measures, the lifestyle modifications and the encouragement to become an actor in the management of his health. The first year, the medical follow-up is recommended at 3, 6 and 12 months.
Read more
Since 2019, in order to reduce the impact of LDL cholesterol, the ESC has recommended that LDL cholesterol levels be lower than 0.55 g/L accompanied by a reduction of at least 50% from their initial value. In 2023, it clarified this recommendation by recommending a laboratory reassessment within 4-6 weeks after hospital discharge.
The application of these recommendations comes up against the difficulties of real life:
- The increase in the number of elderly people and people with one or more chronic diseases;
- In France, the significant regional disparities in the number of physicians;
- In 2022, six months after hospitalization for an ACS, only 21.6% of French patients had benefited from a cardiac rehabilitation program;
- Within 12 months of acute coronary syndrome, only 20% to 40% of patients achieved the LDL cholesterol targets recommended by the ESC.
Given the difficulties in implementing the recommendations, investigators believe it is essential to rethink the care pathway for post-ACS patients.
The investigator's hypothesis is that, in addition to the standard pathway, a care offering access to other healthcare professionals (advanced practice nurse, dietitian, pharmacist) should increase the proportion of patients achieving LDL cholesterol targets (LDL cholesterol < 0.55 g/L and a 50% reduction in this level compared to the baseline value) at 12 months. LDL cholesterol was selected as the endpoint because it has been proven that a reduction in LDL cholesterol corresponds to a 22% reduction in cardiovascular events.
To test this hypothesis, the investigators designed a multicenter controlled and randomized trial with two parallel arms:
- "Routine Cares" arm: Each center will program cares as usual and will schedule patient follow-up according to their wishes (cardiac rehabilitation, visits to the general practitioner and/or cardiologist).
- "Intervention" arm: In addition to routine care as described above, the patient will receive an interdisciplinary consultation one month after hospital discharge and three consultations with the IPA (3, 6, and 12 months).
In order for the conclusions of this protocol to reflect French practices, it is planned to include 230 people who have presented with acute coronary syndrome in four healthcare facilities in France (both in Paris and outside Paris).
- Being tested
- "New" care pathway, "Standard" care pathway
- Keywords
- acute coronary syndrome, dyslipidemias, patient education, multidisciplinary care team, nurse practitioners
- Medical subject headings
- Acute Coronary Syndrome, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"New" care pathwayBehavioural
Also called Interdisciplinaire consultation, Identifying personalized goals, Educational/preventive care, Advanced practice nurse
Initially, the patient will have an interdisciplinary consultation aimed at identifying personalized goals for the patient and providing educational/preventive care using tools that will be provided to all centers. This consultation will bring together a cardiologist, an advanced practice nurse (APN), a dietitian and a pharmacist. This consultation will take place approximately 4 weeks after the hospitalization for acute coronary syndrome (ACS).
Secondly, the patient will have 3 follow-up consultations with the APN (at 3, 6 and 12 months after discharge from hospitalization for an ACS). During these consultations, the APN will perform a clinical assessment, a personalized educational support, a coaching based on the patient's personalized goals, an adjustment of therapies and, depending on needs, referral to other health professionals.
"Standard" care pathwayOther
The French National Health Authority recommends two medical visits (at 6 and 12 month) and, if necessary, a third one (between the first and third month post-ACS) for the monitoring of the left ventricular. - The European Society of Cardiology recommends a reassessment of the lipid profile within 4-6 weeks post-ACS.
| Study group | Role | What they receive |
|---|---|---|
| "Standard" care pathway | Active comparator | Control arm:
* The French National Health Authority recommends two medical visits (at 6 and 12 month) and, if necessary, a third one (between the first and third month post-ACS) for the monitoring of the left ventricular.
* The European Society of Cardiology recommends a reassessment of the lipid profile within 4-6 weeks post-ACS. Receives: Other: "Standard" care pathway |
| "New" care pathway | Experimental | Intervention arm:
In addition to the Standard care pathway:
* One interdisciplinary consultation approximately 4 weeks post-ACS
* Three consultations with the advanced practice nurse at approximately 3 months, 6 months and 12 months post-ACS Receives: Behavioral: "New" care pathway |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients reaching the LDL cholesterol target
The target is definde as LDL cholesterol level <0.55 g/L and >50% reduction from baseline
Measured: At enrollment then at the 12th month
Secondary outcomes (15)
Proportion of patients reaching the LDL cholesterol target
The target for this outcome is defined as LDL cholesterol <0.55 g/L
Measured: At enrollment then at the first month, 6th month and 12th month
Proportion of patients reaching the LDL cholesterol target
The target for this outcome is defined as LDL cholesterol level reduction > 50% compared to baseline value
Measured: At enrollment then at the first month, 6th month and 12th month
Changes in cardiovascular risk factors
This outcome aims to assess changes in the patient's overall cardiovascular risk profile throughout the study. Multiple parameters will be evaluated to capture a comprehensive picture of the modifications in cardiovascular risk factors presented by each patient. The parametrers will be:
- Dyslipidemia: Proportion of patients achieving the LDL cholesterol target set by the European Society of Cardiology (<0.55 g/L and >50% reduction from baseline)
- Hypertension: Proportion of patients achieving a systolic blood pressure < 140 mmHg and a diastolic blood pressure < 90 mmHg
- Percentage of patients with controlled type 2 diabetes (for a diabetic patient, HbA1c target <7%)
- BMI
Measured: At enrollment then at the first month, 6th month and 12th month
Physical Activity Score
Total score on the "Ricci and Gagnon Self-Assessment of Physical Activity" Questionnaire (activity self-assessment questionnaire).
The minimum value is 9 The maximum value is 45 Under 18: inactive Between 18 and 35: active Over 35: very active
Measured: At enrollment then at the 6th month and 12th month
Proportion of patients who participated in a cardiac rehabilitation program
This outcome aims to assess the proportion of patients who engage in a cardiac rehabilitation program following an acute coronary syndrome
Measured: At 6th month and 12th month
Proportion of patients consuming toxic substances and their quantity measured
The substances involved are: alcohol, tobacco, and drugs
Measured: At enrollment then at the 6th month and 12th month
Quality of life score
Measured using the EQ-5D-5L Questionnaire (European quality of life 5 dimensions 5 levels questionnaire) The (EQ-5D-5L) questionnaire provides two types of scores. The first is an index scored derived from five health dimensions (mobility, self-care, actual activities, pain/discomfort, and anxiety/depression) converted into a single value ranged from 0 (representing health states considered worse than death) to 1(representing perfect health). The second is the EQ Visual Analogue Scale (EQ-VAS), a self-rated health measure ranging from 0 ("the worst health you can imagine") to 100 ("the best health you can imagine") representing self-rated health.
Measured: At enrollment then at the 6th month and 12th month
Therapeutic Compliance Score
Measured using FREEDOM questionnaire (FREE Detection non Observance Medication) The FREEDOM questionnaire includes 11 items rated on a 4-point Likert scale ranging from "strongly disagree" to "strongly agree". The questionnaire responses will be used qualitatively, without calculation of a numerical total score, to classify patients into categories of medication adherence (low, moderate, high).
Measured: At enrollment then at the 6th month and 12th month
List of lipid-lowering treatments taken by patients
This outcome aims to describe the lipid-lowering therapy prescribed to each patient, as well as any modifications made during follow-up. This outcome focuses solely on documenting which lipid-lowering treatments patients are receiving and does not involve any comparison or evaluation of the effectiveness or safety of different lipid-lowering therapie
Measured: At enrollment then at the first month, 6th month and 12th month
Number of medical (cardiologist or general practitioner) and/or paramedical (dietician, etc.) consultations
Measured: At 6th month and 12th month
Mortality rate and the reasons
Measured: At 6th month and 12th month
Rehospitalization rates and the reasons
Measured: At 6th month and 12th month
Rate of cardiovascular events
Measured: At 12th month
Estimation of cost per QALY gained and cost per serious cardiac event avoided
QALY: quality-adjusted life year
Measured: At 12th month
Professional satisfaction rate by using a satisfaction scale from 0 to 10
Satisfaction with the care provided to the patient under the EDUSCA protocol
Measured: At 12th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2025
- Study startNov 2025 (estimated)
- Primary completionNov 2028 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary Syndromes (ACS)Studies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Melissa JOLY GOURJAULT, Principal investigator, Hôpital Européen Georges Pompidou - AP-HPThibaut CARUBA, Study chair, Hôpital européen Georges-Pompidou - AP-HP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07178444
- Sponsor's protocol ID
- APHP240952
- Other IDs
- 2025-A00698-41, PHRIP-23-0025
- Acronym
- EDUSCA
- Status last verified
- Sep 2025
- First submitted
- 8 Aug 2025
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of an Interdisciplinary Intervention After Acute Coronary Syndrome on Low-Density Lipoprotein Cholesterol Levels
- ClinicalTrials.gov ID
- NCT07178444
- Acronym / sponsor ID
- EDUSCA / APHP240952
- Keywords
- acute coronary syndrome, dyslipidemias, patient education, multidisciplinary care team, nurse practitioners
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- Nov 2025 (estimated)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 17 Sep 2025 (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.
According to the World Health Organization (WHO), cardiovascular diseases are the worldwide leading cause of death. For the French public health, cardiovascular diseases are the leading cause of death for the women and the second for men. Each year in France, approximately 120,000 acute coronary syndromes (ACS) occur, including 60,000 myocardial infarctions and more than 15,000 deaths. To prevent or reverse this process, the WHO recommends early detection of the diseases and reduce behavioral and cardiovascular risk factors.
For the patient, the European Society of Cardiology (ESC) recommends the implementation of secondary prevention measures, the lifestyle modifications and the encouragement to become an actor in the management of his health. The first year, the medical follow-up is recommended at 3, 6 and 12 months.
Since 2019, in order to reduce the impact of LDL cholesterol, the ESC has recommended that LDL cholesterol levels be lower than 0.55 g/L accompanied by a reduction of at least 50% from their initial value. In 2023, it clarified this recommendation by recommending a laboratory reassessment within 4-6 weeks after hospital discharge.
The application of these recommendations comes up against the difficulties of real life:
- The increase in the number of elderly people and people with one or more chronic diseases;
- In France, the significant regional disparities in the number of physicians;
- In 2022, six months after hospitalization for an ACS, only 21.6% of French patients had benefited from a cardiac rehabilitation program;
- Within 12 months of acute coronary syndrome, only 20% to 40% of patients achieved the LDL cholesterol targets recommended by the ESC.
Given the difficulties in implementing the recommendations, investigators believe it is essential to rethink the care pathway for post-ACS patients.
The investigator's hypothesis is that, in addition to the standard pathway, a care offering access to other healthcare professionals (advanced practice nurse, dietitian, pharmacist) should increase the proportion of patients achieving LDL cholesterol targets (LDL cholesterol < 0.55 g/L and a 50% reduction in this level compared to the baseline value) at 12 months. LDL cholesterol was selected as the endpoint because it has been proven that a reduction in LDL cholesterol corresponds to a 22% reduction in cardiovascular events.
To test this hypothesis, the investigators designed a multicenter controlled and randomized trial with two parallel arms:
- "Routine Cares" arm: Each center will program cares as usual and will schedule patient follow-up according to their wishes (cardiac rehabilitation, visits to the general practitioner and/or cardiologist).
- "Intervention" arm: In addition to routine care as described above, the patient will receive an interdisciplinary consultation one month after hospital discharge and three consultations with the IPA (3, 6, and 12 months).
In order for the conclusions of this protocol to reflect French practices, it is planned to include 230 people who have presented with acute coronary syndrome in four healthcare facilities in France (both in Paris and outside Paris).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| "Standard" care pathway | Active comparator | Other: "Standard" care pathwayControl arm: * The French National Health Authority recommends two medical visits (at 6 and 12 month) and, if necessary, a third one (between the first and third month post-ACS) for the monitoring of the left ventricular. * The European Society of Cardiology recommends a reassessment of the lipid profile within 4-6 weeks post-ACS. |
| "New" care pathway | Experimental | Behavioral: "New" care pathwayIntervention arm: In addition to the Standard care pathway: * One interdisciplinary consultation approximately 4 weeks post-ACS * Three consultations with the advanced practice nurse at approximately 3 months, 6 months and 12 months post-ACS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients hospitalized for ACS (ST+ or ST-), affiliated with a social security scheme, able to understand the protocol and having signed the study consent.
Key exclusion criteria (8 listed)
- Patients with a complication of the ACS (mechanical complication, cardiogenic shock, very severe left ventricular dysfunction, presence of an intraventricular thrombus, complex ventricular rhythm disorder) ;
- Proven cognitive impairment or decompensated psychological/psychiatric disorder ;
- Any progressive inflammatory and/or infectious condition ;
- Any orthopedic problem precluding the physical activity ;
- Current participation in any clinical research project aimed at reducing LDL cholesterol levels ;
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 |
|---|---|---|
| "New" care pathwayAlso: Interdisciplinaire consultation, Identifying personalized goals, Educational/preventive care, Advanced practice nurseInitially, the patient will have an interdisciplinary consultation aimed at identifying personalized goals for the patient and providing educational/preventive care using tools that will be provided to all centers. This consultation will bring together a cardiologist, an advanced practice nurse (APN), a dietitian and a pharmacist. This consultation will take place approximately 4 weeks after the hospitalization for acute coronary syndrome (ACS). Secondly, the patient will have 3 follow-up consultations with the APN (at 3, 6 and 12 months after discharge from hospitalization for an ACS). During these consultations, the APN will perform a clinical assessment, a personalized educational support, a coaching based on the patient's personalized goals, an adjustment of therapies and, depending on needs, referral to other health professionals. | Behavioural | "New" care pathway |
| "Standard" care pathwayThe French National Health Authority recommends two medical visits (at 6 and 12 month) and, if necessary, a third one (between the first and third month post-ACS) for the monitoring of the left ventricular. - The European Society of Cardiology recommends a reassessment of the lipid profile within 4-6 weeks post-ACS. | Other | "Standard" care pathway |
Primary outcome
Proportion of patients reaching the LDL cholesterol target
Time frame: At enrollment then at the 12th month
The target is definde as LDL cholesterol level <0.55 g/L and >50% reduction from baseline
15 secondary outcomes
Proportion of patients reaching the LDL cholesterol target
Time frame: At enrollment then at the first month, 6th month and 12th month
Proportion of patients reaching the LDL cholesterol target
Time frame: At enrollment then at the first month, 6th month and 12th month
Changes in cardiovascular risk factors
Time frame: At enrollment then at the first month, 6th month and 12th month
Physical Activity Score
Time frame: At enrollment then at the 6th month and 12th month
Proportion of patients who participated in a cardiac rehabilitation program
Time frame: At 6th month and 12th month
Proportion of patients consuming toxic substances and their quantity measured
Time frame: At enrollment then at the 6th month and 12th month
Quality of life score
Time frame: At enrollment then at the 6th month and 12th month
Therapeutic Compliance Score
Time frame: At enrollment then at the 6th month and 12th month
List of lipid-lowering treatments taken by patients
Time frame: At enrollment then at the first month, 6th month and 12th month
Number of medical (cardiologist or general practitioner) and/or paramedical (dietician, etc.) consultations
Time frame: At 6th month and 12th month
Mortality rate and the reasons
Time frame: At 6th month and 12th month
Rehospitalization rates and the reasons
Time frame: At 6th month and 12th month
Rate of cardiovascular events
Time frame: At 12th month
Estimation of cost per QALY gained and cost per serious cardiac event avoided
Time frame: At 12th month
Professional satisfaction rate by using a satisfaction scale from 0 to 10
Time frame: At 12th month
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 3 Oct 2025.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared
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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.
Melissa JOLY GOURJAULT principal investigator
Hôpital Européen Georges Pompidou - AP-HP
Thibaut CARUBA study chair
Hôpital européen Georges-Pompidou - AP-HP
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "New" care pathway and "Standard" care pathway in people with Acute Coronary Syndromes (ACS) and Acute Coronary Syndromes, run by Assistance Publique - Hôpitaux de Paris at 4 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 1 inclusion and 8 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: opening soon, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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.
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?
Contact Youcef SEKOUR (0033(0)156095823, youcef.sekour@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients reaching the LDL cholesterol target (time frame: At enrollment then at the 12th month). 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 3 Oct 2025.