POPular GUILTY PILOT: Genotype-guided Clopidogrel Monotherapy (POPular GUILTY)
Acute Coronary Syndrome, CYP2C19 Polymorphism
About this trial
This is an interventional treatment trial for Acute Coronary Syndrome focused on measuring Acute coronary syndrome, Monotherapy, P2Y12 inhibitor, Aspirin free strategy
Eligibility Criteria
Inclusion Criteria: Patients aged 18 years or older are eligible for inclusion if all of the following criteria are met: Clinical diagnosis of NSTE-ACS (i.e. NSTEMI or unstable angina) Successful PCI (according to the treating physician) with implantation of new generation drug eluting stents. CYP2C19 extensive or ultra-rapid metabolizer Exclusion Criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: CYP2C19 poor or intermediate metabolizer Known allergy or contraindication for aspirin or clopidogrel. Concurrent use of oral anticoagulants (e.g. because of atrial fibrillation) Ongoing indication for DAPT at admission (e.g. due to recent PCI or ACS) High-risk features for PCI including left main disease, chronic total occlusion, bifurcation lesion requiring 2-stent treatment, saphenous or arterial graft lesion, severely calcified lesion requiring the use of the Rotablator system, ≥3 treated vessels, ≥ 3 stents implanted and total stent length >60 mm Recent stroke, transient ischemic attack (TIA) or intracranial bleeding Severe hepatic impairment (Child Pugh class C) Planned surgical intervention within 6 months of PCI Patients requiring staged procedure (to avoid heterogeneity in the duration of pharmacological treatment between index and staged procedures) Pregnant or breastfeeding women at time of enrolment Participation in another trial with an investigational drug or device
Sites / Locations
- St. Antonius HospitalRecruiting
Arms of the Study
Arm 1
Experimental
Genotype guided arm
In this study arm, patients with Non-ST-Segment Elevation Acute Coronary Syndrome (NSTE-ACS) who are extensive or ultra-rapid metabolizers as per their CYP2C19 genotype and have undergone successful percutaneous coronary intervention (PCI) will receive a genotype-guided monotherapy. The intervention will be clopidogrel, a potent P2Y12 inhibitor, administered in accordance with the patient's specific genotype. Clopidogrel following PCI will be given with an initial loading dose (300-600mg orally), followed by a maintenance dose of 75mg daily for a defined period, at least 6 months.