MYOCARDIAL INFARCTIONPhase 3ADENNCT05577988
Assessment of an Early De-Escalation to a Low-potency Single Antiplatelet Therapy Guided by Genetics Versus a Systematic High-Potency Single Antiplatelet Therapy to Neutralize Bleeding Complications in Patients With High Bleeding Risk Beyond One Month After an Acute Coronary Syndrome
A Phase 3 study testing single-antiplatelet with a low-potency antiplatelet (aspirin or clopidogrel) guided by genetic testing. in people with MYOCARDIAL INFARCTION, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Patients who suffered from acute coronary syndrome (ACS) are usually treated with a long-term dual antiplatelet therapy (DAPT) to reduce stent thrombosis and recurrent ischemic event. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- MYOCARDIAL INFARCTION
- What is being tested?
- single-antiplatelet with a low-potency antiplatelet (aspirin or clopidogrel) guided by genetic testing.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,468 participants
- Where
- 1 siteFrance
- Study dates
- 18 Jun 2024to Jun 2027
- Phase
- Phase 3
- 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
- Being 18-year-old or older
- Admission for type 1 acute myocardial infarction (STEMI or NSTEMI)
- Bedside genetic testing for clopidogrel resistance that can be performed during hospital stay for ACS (oral swab kit with result within 1 hour)
- Treated with aspirin and ticagrelor, or aspirin and prasugrel at the screening phase and at the randomization visit.
- High bleeding risk as defined below (criteria adapted from the Consensus Document From the Academic Research Consortium for High Bleeding Risk) (at least one criterion) :
- Age ≥75 years old.
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- Baseline haemoglobin <11 g/dl (or anaemia requiring transfusion during the 4 weeks prior to randomization).
- Chronic Kidney Disease with estimated glomerular filtration rate ≤ 30 ml/min.
- Thrombocytopenia with platelet count < 100 x 109 / L
- Chronic bleeding diatheses: inherited or acquired conditions known to be associated with increased bleeding risk such as platelet dysfunction, von Willebrand disease (prevalence of 1%-2% in the general population), inherited or acquired clotting factor deficiencies (including factors VII, VIII [hemophilia A], IX [hemophilia B], and XI), or acquired antibodies to clotting factors, among others.
- Cirrhosis with portal hypertension.
- PCI after major traumatism or surgery.
- Any documented stroke in the last 12 months.
- Hospital admission for bleeding or transfusion within last 6 months.
- Nonskin cancer diagnosed or treated ≤3 years.
- Planned daily nonsteroidal anti-inflammatory drugs (other than aspirin) or steroids for ≥30 days after PCI.
- patient affiliated to a social security system
- signed informed consent form
- Women of childbearing capacity with effective contraception for the duration of the research OR man, OR woman not of childbearing capacity
Who cannot join
- Currently participating in any interventional investigational device or drug trial
- Any prior documented intracerebral bleed
- Contra-indication, known allergy or expected interactions with clopidogrel. Baseline treatment (at screening) should not include an antiplatelet therapy for which a contra-indication, known allergy or expected interactions is known (example history of stroke and use of prasugrel, or concomitant use of ticagrelor and ritonavir)
- Patients on concomitant treatment with an anticoagulant agent (Vitamin-K antagonists or novel oral anticoagulants such as rivaroxaban, dabigatran or apixaban)
- Planned surgery within 12 coming months
- Patient under guardianship or curatorship
- Pregnancy or breastfeeding
- Inability to sign the informed consent form
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hopital Pitié Salpetrière
Paris, IDF, 75013
Michel MD ZEITOUNI, MD,PhD, 33142165535, michel.zeitouni@aphp.fr
Delphine BRUGIER, PhD, 33142162918, delphine.brugier-ext@aphp.fr
About this study
Patients who suffered from acute coronary syndrome (ACS) are usually treated with a long-term dual antiplatelet therapy (DAPT) to reduce stent thrombosis and recurrent ischemic event. Nonetheless, recent important data have demonstrated the efficacy of a short term DAPT and an early single antiplatelet therapy in high bleeding and ischemic risk patients.
The bleeding risk is associated with a significant mortality. This risk is especially high in patients treated with potent P2Y12 inhibitors like ticagrelor or prasugrel after an ACS.
Read more
As a result of the abounding data regarding the safety of an early single antiplatelet therapy with high potency antiplatelet therapy (ticagrelor or prasugrel), it is likely that such strategy will soon be implemented in the guidelines.
The benefits of these high-potency P2Y12 inhibitors over clopidogrel mostly occur in patients with genetic polymorphisms of CYP2Y12 associated with a loss of function in clopidogrel metabolism.
Furthermore, the anti-ischemic benefit of potent P2Y12 inhibitors over clopidogrel occurs early, while excess bleeding events often arise during chronic treatment.
Our hypothesis is that a systematic and rapid genetic screening of CYP2C90 *2 or *17 polymorphism to guide an early single therapy with low potency antiplatelet (aspirin or clopidogrel) could lead to less bleeding events with a consistent efficacy towards cardiac events compared with high potency antiplatelet therapies (prasugrel or ticagrelor) in high bleeding risk patients treated for ACS.
Read the detailed description
Multicenter, randomized, open label trial using the PROBE study design. Randomization 1 to 3 months (preferably 1, considering the HBR) after ACS into 2 parallel arms. Stratification: according to revascularization status (PCI or no PCI), genotype (loss of function, fast metabolization, none) and center.
Control arm: stop aspirin for a single antiplatelet therapy with a high-potency antiplatelet (ticagrelor or prasugrel).
Intervention arm: single-antiplatelet with a low-potency antiplatelet (aspirin or clopidogrel) guided by genetic testing.
- Conditions
- MYOCARDIAL INFARCTION
- Being tested
- single-antiplatelet with a low-potency antiplatelet (aspirin or clopidogrel) guided by genetic testing.
- Keywords
- Acute Coronary Syndrome, High Bleeding Risk, Antiplatelet Therapy
- Medical subject headings
- Myocardial Infarction, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
single-antiplatelet with a low-potency antiplatelet (aspirin or clopidogrel) guided by genetic testing.Other
- Individuals without genetic loss of function to metabolize clopidogrel (*1/*1, *2/*17, *3/*17): stop DAPT and switch to a single antiplatelet therapy by clopidogrel.
- Individuals with genetic loss of function to metabolize clopidogrel (*2/*3, 1/*3, *2/*2, *1/*2,*3/*3): stop potent P2Y12 inhibitor and treat with a single antiplatelet therapy by aspirin.
- Individuals with fast metabolization of clopidogrel (*1/*17 or *17/*17): stop potent P2Y12 inhibitor and treat with a single antiplatelet therapy by aspirin.
| Study group | Role | What they receive |
|---|---|---|
| Control arm | No intervention | Standard of Care : Systematic de-escalation to a high potency antiplatelet single therapy |
| Intervention arm | Other | single-antiplatelet with a low-potency antiplatelet (aspirin or clopidogrel) guided by genetic testing. Receives: Other: single-antiplatelet with a low-potency antiplatelet (aspirin or clopidogrel) guided by genetic testing. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of combinated major and minor bleeding events (BARC 2 to 5 BARC)
the occurrence of major or minor bleeding events between randomization to one of the de-escalation strategies and 1 year after index ACS defined according to the Bleeding Academic Research Consortium (BARC) classification as type 2 to 5
Measured: From randomization (1-3months after inclusion) to 1year after inclusion
Secondary outcomes (3)
Rate of major adverse cardiovascular events
major adverse cardiovascular events defined as follow and in the following hierarchical order:
- Death or myocardial infarction or stroke or stent thrombosis (key secondary)
- Death or Myocardial infarction
Measured: From randomization to de-escalation (1-3months) to 1year
Rate of major bleeding events
the occurrence of major bleeding events between randomization to one of the de-escalation strategies and 1 year after index ACS defined according to the Bleeding Academic Research Consortium (BARC) classification
Measured: randomization to de-escalation (1-3months) to 1year
Rate of minor bleeding events
the occurrence of minor bleeding events between randomization to one of the de-escalation strategies and 1 year after index ACS defined according to the Bleeding Academic Research Consortium (BARC) classification
Measured: randomization to de-escalation (1-3months) to 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start18 Jun 2024
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MYOCARDIAL INFARCTIONStudies 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 3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- National, multicentre, comparative, controlled, randomized, open label trial using the PROBE study design (Prospective Randomized Open Blinded End-point)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2,468 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Fonds de Dotation ACTION
- Responsible party
- Sponsor
- Investigators
- Michel ZEITOUNI, MD, PhD, Study chair, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05577988
- Sponsor's protocol ID
- APHP211027
- Other IDs
- 20-0570 PHRC
- Acronym
- ADEN
- Status last verified
- Jan 2026
- First submitted
- 10 Oct 2022
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of an Early De-Escalation to a Low-potency Single Antiplatelet Therapy Guided by Genetics Versus a Systematic High-Potency Single Antiplatelet Therapy to Neutralize Bleeding Complications in Patients With High Bleeding Risk Beyond One Month After an Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT05577988
- Acronym / sponsor ID
- ADEN / APHP211027
- Conditions
- MYOCARDIAL INFARCTION
- Keywords
- Acute Coronary Syndrome, High Bleeding Risk, Antiplatelet Therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,468 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Fonds de Dotation ACTION
- Study start
- 18 Jun 2024 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 13 Oct 2022 (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 who suffered from acute coronary syndrome (ACS) are usually treated with a long-term dual antiplatelet therapy (DAPT) to reduce stent thrombosis and recurrent ischemic event. Nonetheless, recent important data have demonstrated the efficacy of a short term DAPT and an early single antiplatelet therapy in high bleeding and ischemic risk patients.
The bleeding risk is associated with a significant mortality. This risk is especially high in patients treated with potent P2Y12 inhibitors like ticagrelor or prasugrel after an ACS.
As a result of the abounding data regarding the safety of an early single antiplatelet therapy with high potency antiplatelet therapy (ticagrelor or prasugrel), it is likely that such strategy will soon be implemented in the guidelines.
The benefits of these high-potency P2Y12 inhibitors over clopidogrel mostly occur in patients with genetic polymorphisms of CYP2Y12 associated with a loss of function in clopidogrel metabolism.
Furthermore, the anti-ischemic benefit of potent P2Y12 inhibitors over clopidogrel occurs early, while excess bleeding events often arise during chronic treatment.
Our hypothesis is that a systematic and rapid genetic screening of CYP2C90 *2 or *17 polymorphism to guide an early single therapy with low potency antiplatelet (aspirin or clopidogrel) could lead to less bleeding events with a consistent efficacy towards cardiac events compared with high potency antiplatelet therapies (prasugrel or ticagrelor) in high bleeding risk patients treated for ACS.
Detailed description
Multicenter, randomized, open label trial using the PROBE study design. Randomization 1 to 3 months (preferably 1, considering the HBR) after ACS into 2 parallel arms. Stratification: according to revascularization status (PCI or no PCI), genotype (loss of function, fast metabolization, none) and center.
Control arm: stop aspirin for a single antiplatelet therapy with a high-potency antiplatelet (ticagrelor or prasugrel).
Intervention arm: single-antiplatelet with a low-potency antiplatelet (aspirin or clopidogrel) guided by genetic testing.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- National, multicentre, comparative, controlled, randomized, open label trial using the PROBE study design (Prospective Randomized Open Blinded End-point)
| Arm | Type | Receives |
|---|---|---|
| Control arm | No intervention | –Standard of Care : Systematic de-escalation to a high potency antiplatelet single therapy |
| Intervention arm | Other | Other: single-antiplatelet with a low-potency antiplatelet (aspirin or clopidogrel) guided by genetic testing.single-antiplatelet with a low-potency antiplatelet (aspirin or clopidogrel) guided by genetic testing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Being 18-year-old or older
- Admission for type 1 acute myocardial infarction (STEMI or NSTEMI)
- Bedside genetic testing for clopidogrel resistance that can be performed during hospital stay for ACS (oral swab kit with result within 1 hour)
- Treated with aspirin and ticagrelor, or aspirin and prasugrel at the screening phase and at the randomization visit.
- High bleeding risk as defined below (criteria adapted from the Consensus Document From the Academic Research Consortium for High Bleeding Risk) (at least one criterion) :
Key exclusion criteria (8 listed)
- Currently participating in any interventional investigational device or drug trial
- Any prior documented intracerebral bleed
- Contra-indication, known allergy or expected interactions with clopidogrel. Baseline treatment (at screening) should not include an antiplatelet therapy for which a contra-indication, known allergy or expected interactions is known (example history of stroke and use of prasugrel, or concomitant use of ticagrelor and ritonavir)
- Patients on concomitant treatment with an anticoagulant agent (Vitamin-K antagonists or novel oral anticoagulants such as rivaroxaban, dabigatran or apixaban)
- Planned surgery within 12 coming months
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 |
|---|---|---|
| single-antiplatelet with a low-potency antiplatelet (aspirin or clopidogrel) guided by genetic testing.* Individuals without genetic loss of function to metabolize clopidogrel (*1/*1, *2/*17, *3/*17): stop DAPT and switch to a single antiplatelet therapy by clopidogrel. * Individuals with genetic loss of function to metabolize clopidogrel (*2/*3, 1/*3, *2/*2, *1/*2,*3/*3): stop potent P2Y12 inhibitor and treat with a single antiplatelet therapy by aspirin. * Individuals with fast metabolization of clopidogrel (*1/*17 or *17/*17): stop potent P2Y12 inhibitor and treat with a single antiplatelet therapy by aspirin. | Other | Intervention arm |
Primary outcome
Rate of combinated major and minor bleeding events (BARC 2 to 5 BARC)
Time frame: From randomization (1-3months after inclusion) to 1year after inclusion
the occurrence of major or minor bleeding events between randomization to one of the de-escalation strategies and 1 year after index ACS defined according to the Bleeding Academic Research Consortium (BARC) classification as type 2 to 5
3 secondary outcomes
Rate of major adverse cardiovascular events
Time frame: From randomization to de-escalation (1-3months) to 1year
Rate of major bleeding events
Time frame: randomization to de-escalation (1-3months) to 1year
Rate of minor bleeding events
Time frame: randomization to de-escalation (1-3months) to 1year
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 16 Jan 2026.
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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.
Michel ZEITOUNI, MD, PhD study chair
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing single-antiplatelet with a low-potency antiplatelet (aspirin or clopidogrel) guided by genetic testing. in people with MYOCARDIAL INFARCTION, run by Assistance Publique - Hôpitaux de Paris at 1 site 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 19 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: looking for participants now, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Contact Michel ZEITOUNI, MD,PhD (33142165535, michel.zeitouni@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of combinated major and minor bleeding events (BARC 2 to 5 BARC) (time frame: From randomization (1-3months after inclusion) to 1year after inclusion). 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 16 Jan 2026.