Actively Recruiting
POPular GUILTY PILOT: Genotype-guided Clopidogrel Monotherapy
Led by St. Antonius Hospital · Updated on 2024-12-03
200
Participants Needed
1
Research Sites
182 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
POPular GUILTY PILOT: Genotype-guided Clopidogrel Monotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years or older
- Clinical diagnosis of Non-ST-Segment Elevation Acute Coronary Syndrome (NSTEMI or unstable angina)
- Successful Percutaneous Coronary Intervention with implantation of new generation drug eluting stents
- CYP2C19 extensive or ultra-rapid metabolizer
You will not qualify if you...
- CYP2C19 poor or intermediate metabolizer
- Known allergy or contraindication for aspirin or clopidogrel
- Concurrent use of oral anticoagulants
- Ongoing indication for dual antiplatelet therapy at admission
- 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 Rotablator system, 3 or more treated vessels, 3 or more stents implanted, or total stent length greater than 60 mm
- Recent stroke, transient ischemic attack, or intracranial bleeding
- Severe hepatic impairment (Child Pugh class C)
- Planned surgical intervention within 6 months of PCI
- Patients requiring staged procedure
- Pregnant or breastfeeding women at time of enrolment
- Participation in another trial with an investigational drug or device
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
St. Antonius Hospital
Nieuwegein, Utrecht, Netherlands
Actively Recruiting
Research Team
J
Jaouad Azzahhafi, MD
CONTACT
J
Jurrien ten Berg, MD PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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