POPular GUILTY PILOT: Genotype-guided Clopidogrel Monotherapy

Launched by ST. ANTONIUS HOSPITAL · Jun 27, 2023

Keywords

ClinConnect Summary

The POPular GUILTY PILOT trial is studying a new approach to treating patients with a condition called Non-ST-Segment Elevation Acute Coronary Syndrome (NSTE-ACS), which often requires a procedure called Percutaneous Coronary Intervention (PCI). In this trial, researchers want to find out if a personalized treatment using a medication called clopidogrel—guided by each patient's genetic makeup—can safely reduce the risk of serious heart problems (ischemic events) while also minimizing bleeding risks after the PCI procedure. Participants who meet specific criteria, such as being 18 years or older and having undergone successful PCI with certain types of stents, may be eligible to join the study.

If you participate, you will receive the genotype-guided clopidogrel treatment and be monitored for six months for any complications, both in terms of heart issues and bleeding. The researchers will compare your outcomes to those of patients receiving standard dual antiplatelet therapy, which involves taking two medications. This trial is important because it could provide valuable information about a safer and effective treatment option for patients like you after heart procedures.

Gender

ALL

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