Genotype-guided clopidogrel treatment for heart patients

POPular GUILTY PILOT: Genotype-guided Clopidogrel Monotherapy

This study is testing if giving heart patients a blood thinner based on their genes can help them avoid complications better than the usual treatment after a heart procedure.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: St. Antonius Hospital (Academic / other)
• Locations: 1 site (Nieuwegein, Utrecht)
• Trial ID: NCT05926271 on ClinicalTrials.gov

What this trial studies

This pilot clinical trial aims to evaluate the safety and effectiveness of genotype-guided clopidogrel monotherapy in patients with Non-ST-Segment Elevation Acute Coronary Syndrome (NSTE-ACS) who have successfully undergone Percutaneous Coronary Intervention (PCI). Participants will receive clopidogrel based on their genetic profile and will be monitored for bleeding and ischemic complications over six months. The study seeks to determine if this approach can reduce ischemic risk while minimizing bleeding compared to traditional dual antiplatelet therapy. The findings will help assess whether genotype-guided treatment can be a viable alternative for these patients.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a clinical diagnosis of NSTE-ACS who are CYP2C19 extensive or ultra-rapid metabolizers and have undergone successful PCI.

Not a fit: Patients who are CYP2C19 poor or intermediate metabolizers or those with contraindications to clopidogrel or aspirin will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a safer and more effective treatment option for patients with NSTE-ACS, reducing the risk of complications.

How similar studies have performed: Previous studies have shown promising results for genotype-guided antiplatelet therapy, suggesting potential success for this novel approach.

Eligibility criteria

Inclusion Criteria:

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

Exclusion Criteria:

A potential subject who meets any of the following criteria will be excluded from participation in this study:

* 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)
* 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)
* Planned surgical intervention within 6 months of PCI
* Patients requiring staged procedure (to avoid heterogeneity in the duration of pharmacological treatment between index and staged procedures)
* Pregnant or breastfeeding women at time of enrolment
* Participation in another trial with an investigational drug or device

Where this trial is running

Nieuwegein, Utrecht

• St. Antonius Hospital — Nieuwegein, Utrecht, Netherlands (Recruiting)

Study contacts

• Study coordinator: Jaouad Azzahhafi, MD

Conditions Acute Coronary Syndrome; CYP2C19 Polymorphism; Acute coronary syndrome; Monotherapy; P2Y12 inhibitor; Aspirin free strategy