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POPular GUILTY PILOT: Genotype-guided Clopidogrel Monotherapy

NCT05926271 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2024-12-03

No results posted yet for this study

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.

Conditions

  • Acute Coronary Syndrome
  • CYP2C19 Polymorphism

Interventions

DRUG

Clopidogrel

See arm description earlier.

Sponsors & Collaborators

  • St. Antonius Hospital

    lead OTHER

Principal Investigators

  • Ashley Verburg, MD · St. Antonius Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-07-15
Primary Completion
2026-06-15
Completion
2027-01-15

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05926271 on ClinicalTrials.gov