POPular GUILTY PILOT: Genotype-guided Clopidogrel Monotherapy
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSt. Antonius Hospital
About this trial
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
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Single group
Treatments tested in this trial
Clopidogrel
DrugSee arm description earlier.
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: Genotype guided armExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Primary efficacy endpoint
A composite endpoint consisting of all-cause mortality, myocardial infarction, probable and definite Stent Thrombosis and ischemic stroke (the first event that occurs will be counted for this composite endpoint)
Time frame
6 months2
Primary safety endpoint
Composite endpint consisting of major or clinically relevant non-major bleeding (BARC type 2, 3 or 5 bleeding)
Time frame
6 monthsSecondary outcomes
1
Mortality
all-cause mortality
Time frame
3 and 6 months2
Myocardial infarction
Myocardial infarction
Time frame
3 and 6 months3
Stent thrombosis
Probable and definite Stent Thrombosis
Time frame
3 and 6 months4
Ischemic stroke
ischemic stroke
Time frame
3 and 6 monthsSponsors and contacts
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Source ClinicalTrials.gov