POPular GUILTY PILOT: Genotype-guided Clopidogrel Monotherapy

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
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⁃ 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

Locations
Other Locations
Netherlands
St. Antonius Hospital
RECRUITING
Nieuwegein
Contact Information
Primary
Jaouad Azzahhafi, MD
j.azzahhafi@antoniusziekenhuis.nl
+31883201321
Backup
Jurrien ten Berg, MD PhD
j.ten.berg@antoniusziekenhuis.nl
+31883201321
Time Frame
Start Date: 2023-07-15
Estimated Completion Date: 2027-01-15
Participants
Target number of participants: 200
Treatments
Experimental: Genotype guided arm
In this study arm, patients with Non-ST-Segment Elevation Acute Coronary Syndrome (NSTE-ACS) who are extensive or ultra-rapid metabolizers as per their CYP2C19 genotype and have undergone successful percutaneous coronary intervention (PCI) will receive a genotype-guided monotherapy.~The intervention will be clopidogrel, a potent P2Y12 inhibitor, administered in accordance with the patient's specific genotype. Clopidogrel following PCI will be given with an initial loading dose (300-600mg orally), followed by a maintenance dose of 75mg daily for a defined period, at least 6 months.
Sponsors
Leads: St. Antonius Hospital

This content was sourced from clinicaltrials.gov

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