NCT05577988RecruitingPhase 3
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
Source: ClinicalTrials.gov · Last updated 16 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 2468 (estimated)
- First submitted
- 10 Oct 2022
- Start date
- 18 Jun 2024
- Primary completion date
- Jun 2027
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Diseases
- Coronary artery disease
- NCT number
- NCT05577988
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 2468
- From 18 Jun 2024 to the primary completion date, Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other
- Patient under guardianship or curatorship
- Pregnancy or breastfeeding
- Inability to sign the informed consent form
Who the study is looking for
- 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.
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hopital Pitie-Salpetriere Coordinator of this site? Confirm its status | Paris | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.