NCT05926271 POPular GUILTY PILOT: Genotype-guided Clopidogrel Monotherapy
| NCT ID | NCT05926271 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | St. Antonius Hospital |
| Condition | Acute Coronary Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2023-07-15 |
| Primary Completion | 2026-06-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 200 participants in total. It began in 2023-07-15 with a primary completion date of 2026-06-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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
Contact & Investigator
Ashley Verburg, MD
STUDY DIRECTOR
St. Antonius Hospital
Frequently Asked Questions
Who can join the NCT05926271 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Coronary Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05926271 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05926271 currently recruiting?
Yes, NCT05926271 is actively recruiting participants. Contact the research team at j.azzahhafi@antoniusziekenhuis.nl for enrollment information.
Where is the NCT05926271 trial being conducted?
This trial is being conducted at Nieuwegein, Netherlands.
Who is sponsoring the NCT05926271 clinical trial?
NCT05926271 is sponsored by St. Antonius Hospital. The principal investigator is Ashley Verburg, MD at St. Antonius Hospital. The trial plans to enroll 200 participants.