POPular GUILTY PILOT: Genotype-guided Clopidogrel Monotherapy

Recruiting now · Phase 2

Conditions studied: Acute Coronary Syndrome, CYP2C19 Polymorphism

In brief

The goal of this pilot clinical trial is to test the safety and effectiveness of genotype-guided clopidogrel monotherapy in patients presenting with Non-ST-Segment Elevation Acute Coronary Syndrome (NSTE-ACS) who have undergone successful Percutaneous Coronary Intervention (PCI). The main questions it aims to answer are: * Is genotype-guided clopidogrel monotherapy effective in reducing ischemic risk during the first six months following successful PCI? * Is genotype-guided clopidogrel monotherapy safe in terms of reducing bleeding risk during the first six months following successful PCI? Participants will be given genotype-guided clopidogrel monotherapy after their successful PCI procedure and will be monitored for any bleeding or ischemic complications over the next six months. Researchers will compare these results to the typical outcomes associated with traditional Dual antiplatelet therapy (DAPT) to see if genotype-guided clopidogrel monotherapy provides similar or improved protection from ischemic events, but with fewer bleeding complications.

Key facts

Study ID

NCT05926271

Run by

St. Antonius Hospital

People needed

200

Starts

2023-07-15

Expected to finish

2027-01-15

Last updated by the study team

2024-12-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• St. Antonius Hospital — Nieuwegein, Utrecht, Netherlands (enrolling)

Full record on ClinicalTrials.gov

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