Phase
Condition
Coronary Artery Disease
Congestive Heart Failure
Circulation Disorders
Treatment
single-antiplatelet with a low-potency antiplatelet (aspirin or clopidogrel) guided by genetic testing.
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 duringhospital stay for ACS (oral swab kit with result within 1 hour)
Treated with aspirin and ticagrelor, or aspirin and prasugrel at the screening phaseand at the randomization visit.
High bleeding risk as defined by the Consensus Document From the Academic ResearchConsortium for High Bleeding Risk (at least one criterion) :
Age ≥75 years old.
Baseline haemoglobin <11 g/dl (or anaemia requiring transfusion during the 4weeks 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 beassociated with increased bleeding risk such as platelet dysfunction, vonWillebrand disease (prevalence of 1%-2% in the general population), inheritedor acquired clotting factor deficiencies (including factors VII, VIII [hemophilia A], IX [hemophilia B], and XI), or acquired antibodies to clottingfactors, 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) orsteroids 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 usedup to the visit V3
Exclusion
Exclusion Criteria:
Enrolled in another clinical trial except non interventional studies
Any prior documented intracerebral bleed
Contra-indication, known allergy or expected interactions with clopidogrel. Baselinetreatment (at screening) should not include an antiplatelet therapy for which acontra-indication, known allergy or expected interactions is known (example historyof stroke and use of prasugrel, or concomitant use of ticagrelor and ritonavir)
Patients on concomitant treatment with an anticoagulant agent (Vitamin-K antagonistsor 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
Study Design
Study Description
Connect with a study center
Hopital Pitié Salpetrière
Paris, IDF 75013
FranceActive - Recruiting
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