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Compares treatment options for MYOCARDIAL INFARCTION
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
What this study is testing
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
You likely can't join if
- Currently participating in any treatment 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...
- Patients on concomitant treatment with an anticoagulant agent (Vitamin-K antagonists or novel oral anticoagulants such as rivaroxaban, dabigatran or...
- Planned surgery within 12 coming months
- Patient under guardianship or curatorship
See the full eligibility 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 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)...
- 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
- Currently participating in any treatment 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Paris, IDF, France
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Paris, IDF, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.