NCT05773989CompletedPhase 4
Individualized anti-platelet therapy in patients with stable coronary artery disease undergoing stenting
Pharmacodynamic Outcomes in patients with coronary artery disease undergoing Percutaneous coronary intervention treated with an individualized treatment STRATEGY (POPular STRATEGY PD)
Source: EU CTIS (euclinicaltrials.eu) · Last updated 26 Aug 2024
Brief summary (registry, in English)
The aim of this study is to assess if a CYP2C19 genotype guided P2Y12-inhibitor monotherapy improves P2Y12-receptor mediated platelet inhibition by measuring platelet reactivity units using the VerifyNow. The primary end point of our study will be levels of platelet reactivity, measured as PRU using the VerifyNow system, of CYP2C19 genotype guided P2Y12-inhibitor monotherapy versus standard DAPT at 30 days after randomization.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 88 (actual)
- First submitted
- 22 Mar 2023
- Start date
- 11 Jan 2024
- Lead sponsor
- St Antonius Hospital
- Diseases
- Coronary artery disease
- NCT number
- NCT05773989
- EU CT number
- 2023-504078-39-01
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 88
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Treatment with a strong CYP3A4 inhibitor or inducer
- Treatment with a strong CYP2C19 inhibitor or inducer
Other illness
- Planned cardiac valve surgery
- History of definite stent thrombosis
Other
- Contraindication to aspirin
- Suboptimal result of stenting as defined by the operator, preferably explained according the complex-PCI criteria
- Contraindication to ticagrelor, prasugrel or clopidogrel
- Need for chronic oral anticoagulation
- PCI when admitted for ACS
- Life expectancy < 1 year
- Unable or unwilling to provide informed consent
- Pregnancy
Who the study is looking for
- Patients of 18 years or older
- Patients with Chronic Coronary Syndrome (CCS) undergoing successful elective percutaneous coronary intervention (PCI)
- Patients with written informed consent as approved by the ethics committee
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| St. Antonius Hospital Coordinator of this site? Confirm its status | Nieuwegein | Netherlands | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.