Individualized treatment for patients with coronary artery disease
Pharmacodynamic Outcomes in Patients With Coronary Artery Disease Undergoing Percutaneous Coronary Intervention Treated With an Individualized Treatment STRATEGY
This study is testing if using a personalized blood-thinning treatment based on patients' genes can help people with coronary artery disease have better outcomes and fewer side effects after heart procedures.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 88 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | St. Antonius Hospital Academic / other |
| Locations | 1 site (Nieuwegein, Utrecht) |
| Trial ID | NCT05773989 on ClinicalTrials.gov |
What this trial studies
This study evaluates the pharmacodynamic response of patients with Chronic Coronary Syndrome (CCS) undergoing elective percutaneous coronary intervention (PCI) when treated with genotype-guided P2Y12-inhibitor monotherapy compared to standard dual antiplatelet therapy (DAPT). Patients will be randomized to receive either clopidogrel monotherapy or a P2Y12-inhibitor based on their CYP2C19 genotype. The study aims to assess bleeding and ischemic outcomes over a 6-month period. By personalizing treatment based on genetic factors, the study seeks to optimize patient outcomes while minimizing risks associated with antithrombotic therapy.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with Chronic Coronary Syndrome undergoing elective PCI.
Not a fit: Patients with contraindications to the study medications or those with a life expectancy of less than one year may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more effective and safer antithrombotic therapy for patients with coronary artery disease.
How similar studies have performed: Other studies have shown promise with genotype-guided antithrombotic strategies, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients ≥ 18 years of age * Patients with CCS undergoing successful elective PCI * Patients with written informed consent as approved by the ethics committee Exclusion Criteria: * Contraindication to aspirin, ticagrelor, prasugrel or clopidogrel * Under the age of 18 years * Planned cardiac valve surgery * Need for chronic oral anticoagulation * PCI when admitted for ACS * Life expectancy \< 1 year * Unable or unwilling to provide informed consent * Pregnancy * Suboptimal result of stenting as defined by the operator, preferably explained according the complex-PCI criteria * Treatment with a strong CYP3A4 inhibitor or inducer * Treatment with a strong CYP2C19 inhibitor or inducer * History of definite stent thrombosis
Where this trial is running
Nieuwegein, Utrecht
- St. Antonius Hospital — Nieuwegein, Utrecht, Netherlands (Recruiting)
Study contacts
- Principal investigator: Jurriën ten Berg, MD, PhD — St. Antonius Hospital
- Study coordinator: Wout van den Broek, MD
- Email: w.van.den.broek2@antoniusziekenhuis.nl
- Phone: 088 320 1337
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.