Informations générales (source: ClinicalTrials.gov)
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
Interventional
Phase 3
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
juin 2024
janvier 2026
17 septembre 2025
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CENTRE CARDIOLOGIQUE DU NORD | ZEITOUNI Michel | 01/11/2025 07:54:32 | Contacter | ||
| CH DE VERSAILLES SITE ANDRE MIGNOT | ZEITOUNI Michel | 01/11/2025 07:54:31 | Contacter | ||
| AP-HP Assistance publique - Hôpitaux de Paris | 01/11/2025 07:54:32 | Contacter | |||
| AP-HP - Hôpital Ambroise Paré | |||||
| AP-HP - Hôpital Europeen Georges Pompidou | |||||
| AP-HP - Hôpital La Pitié-Salpêtrière | |||||
| AP-HP - Hôpital Lariboisiere-Fernand Widal | |||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Hopital Pitié Salpetrière - 75013 - Paris - IDF - France | Michel MD ZEITOUNI, MD,PhD | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- 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 by the Consensus Document From the Academic Research
Consortium for High Bleeding Risk (at least one criterion) :
- Age ≥75 years old.
- 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
- For women of childbearing potential, an effective contraception method must be used
up to the visit V3
- 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 by the Consensus Document From the Academic Research
Consortium for High Bleeding Risk (at least one criterion) :
- Age ≥75 years old.
- 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
- For women of childbearing potential, an effective contraception method must be used
up to the visit V3
- Enrolled in another clinical trial except non interventional studies
- 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