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Recruiting Phase 2 NCT05926271

POPular GUILTY PILOT: Genotype-guided Clopidogrel Monotherapy

Trial Parameters

Condition Acute Coronary Syndrome
Sponsor St. Antonius Hospital
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 200
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2023-07-15
Completion 2026-06-15
Interventions
Clopidogrel

Brief Summary

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.

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 st

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