Actively Recruiting
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
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2026-01-16
2468
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
A
Assistance Publique - Hôpitaux de Paris
Lead Sponsor
F
Fonds de Dotation ACTION
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating treatments for patients who have experienced acute coronary syndrome (ACS), focusing on reducing bleeding risks while maintaining protection against heart-related events. This phase 3 randomized trial compares two approaches: a high-potency single antiplatelet therapy versus an early switch to a low-potency single antiplatelet therapy guided by genetic testing. The study addresses the challenge that potent medications like ticagrelor or prasugrel, while effective, can increase bleeding risk, which is linked to higher mortality in these patients. Participants are randomly assigned 1 to 3 months after their ACS event to either continue a high-potency antiplatelet therapy (ticagrelor or prasugrel) or switch to a low-potency antiplatelet therapy (aspirin or clopidogrel) based on their genetic profile for clopidogrel metabolism. The control group stops aspirin and continues with the potent antiplatelet, while the intervention group uses genetic testing to guide treatment choice. Stratification considers revascularization status, genotype, and center. The intervention uses bedside genetic testing with rapid results to determine the appropriate medication. Throughout the one-year follow-up, participants undergo monitoring for bleeding events and cardiovascular outcomes. Researchers assess the combined rate of major and minor bleeding as the primary outcome, alongside secondary measures like major adverse cardiovascular events and separate rates of major or minor bleeding. Safety and efficacy are tracked from randomization until one year later. Participants remain under regular clinical evaluation and provide informed consent, with their medical care supervised throughout the trial.
CONDITIONS
Brief 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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 at least one of the following: age 75 years or older; baseline hemoglobin less than 11 g/dl or anemia requiring transfusion within 4 weeks prior; chronic kidney disease with estimated glomerular filtration rate 30 ml/min or less; thrombocytopenia with platelet count less than 100 x 10^9/L; chronic bleeding disorders such as platelet dysfunction or clotting factor deficiencies; cirrhosis with portal hypertension; PCI after major trauma or surgery; documented stroke in last 12 months; hospital admission for bleeding or transfusion within last 6 months; nonskin cancer diagnosed or treated within 3 years; planned daily use of nonsteroidal anti-inflammatory drugs 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
You will not qualify if you...
- Currently participating in any interventional investigational device or drug trial
- Any prior documented intracerebral bleed
- Contraindication, known allergy, or expected interactions with clopidogrel or other antiplatelet therapies
- Patients on concomitant treatment with anticoagulant agents such as Vitamin-K antagonists or novel oral anticoagulants
- Planned surgery within the next 12 months
- Patient under guardianship or curatorship
- Pregnancy or breastfeeding
- Inability to sign the informed consent form
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - From 1 to 3 months up to 1 year
Participants receive either a low-potency single antiplatelet therapy guided by genetic testing or a high-potency single antiplatelet therapy after randomization 1 to 3 months following an acute coronary syndrome.
Trial Site Locations
Total: 1 location
1
Hopital Pitié Salpetrière
Paris, IDF, France, 75013
Actively Recruiting
Research Team
M
Michel ZEITOUNI, MD,PhD
D
Delphine BRUGIER, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here