POPular GUILTY PILOT: Genotype-guided Clopidogrel monotherapy
Key facts
- Where
- Nieuwegein, HollandiaSee the site
- Phase
- 4. fázis
Where in Hollandia
- Sint Antonius Ziekenhuis StichtingNieuwegein, HollandiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Sint Antonius Ziekenhuis Stichting
- Trial code
- EU 2024-518464-12-00
- Record updated
- 2026. január 29.
- Original description
1. To assess ischemic risk (i.e. efficacy) of genotype-guided clopidogrel monotherapy during the first 6 months following successful PCI in NSTE-ACS patients. 2. To assess bleeding risk (i.e. safety) of genotype-guided clopidogrel monotherapy during the first 6 months following successful PCI in NSTE-ACS patients.Read full original descriptionShow less
1. To assess ischemic risk (i.e. efficacy) of genotype-guided clopidogrel monotherapy during the first 6 months following successful PCI in NSTE-ACS patients. 2. To assess bleeding risk (i.e. safety) of genotype-guided clopidogrel monotherapy during the first 6 months following successful PCI in NSTE-ACS patients.
Inclusion: Age 18 or older; Clinical diagnosis of NSTE-ACS (i.e. NSTEMI or unstable angina); Successful PCI (according to the treating physician); CYP2C19 extensive or ultra-rapid metabolizer.
Exclusion: Planned surgical intervention within 6 months of PCI; Participation in another trial with an investigational drug or device; Concurrent use of oral anticoagulants (e.g. because of atrial fibrillation); Known allergy or contraindication for aspirin or clopidogrel; 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); CYP2C19 poor or intermediate metabolizer; Pregnant or breastfeeding women at time of enrolment; Ongoing indication for DAPT at admission (e.g. due to recent PCI or ACS).