Pharmacodynamic Outcomes in Patients With Coronary Artery Disease Undergoing Percutaneous Coronary Intervention Treated With an Individualized Treatment STRATEGY

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

Patients with Chronic Coronary Syndrome (CCS) undergoing with elective percutaneous coronary intervention (PCI) are treated with dual antiplatelet therapy (DAPT), consisting of aspirin combined with clopidogrel for 6 months. The aim of DAPT is to prevent recurrent thrombotic events, i.e. death, stent thrombosis and/ or myocardial infarction (MI). However, the trade-off of thrombotic prevention by DAPT is an increased risk of bleeding. Multiple strategies to reduce bleeding risk and optimize outcomes have been proposed. On one hand the bleeding risk can be reduced by shortening the duration of DAPT and omitting aspirin. This has been proven effective in patients with acute coronary syndromes (ACS) compared to standard DAPT, without a significant difference in thrombotic events. On the other hand, personalized medicine by means of genotyping to ensure that a patient is treated with an, for them, effective drug, can be a strategy to optimize patients outcomes. In CCS patients the preferred P2Y12-inhibitor is clopidogrel. However, clopidogrel must first be activated by the CYP2C19 enzyme in the liver. Only then can clopidogrel inhibit the P2Y12-receptor and prevent platelet activation. Almost thirty percent of patients has a genetic variation of the gene encoding this CYP2C19 enzyme. In these patients, clopidogrel is not or hardly activated, putting them at a higher risk of thrombotic events than patients who do not have this gene variation. By determining the CYP2C19 genotype, it is possible to estimate whether clopidogrel will be effective or not. In this trial the investigators evaluate the pharmacodynamic effects of genotype guided P2Y12-inhibitor monotherapy in patients with CCS undergoing PCI. In the intervention arm the CYP2C19 genotype will be assessed using a point-of-care test device on the cardiology ward, which can be performed by (research) nurses. Patients with a CYP2C19 loss-of-function (LOF) allel will be treated with monotherapy ticagrelor or prasugrel. Patients who are non-carrier of a LOF allel will receive clopidogrel. The control arm will be treated with the current standard-of-care, which is DAPT, consisting of aspirin combined with clopidogrel for 6 months. The main goals is to assess the antithrombotic effects of individualized P2Y12 monotherapy strategy versus clopidogrel plus aspirin in elective PCI patients.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients ≥ 18 years of age

• Patients with CCS undergoing successful elective PCI

• Patients with written informed consent as approved by the ethics committee

Locations
Other Locations
Netherlands
St. Antonius Hospital
RECRUITING
Nieuwegein
Contact Information
Primary
Wout van den Broek, MD
w.van.den.broek2@antoniusziekenhuis.nl
088 320 1337
Time Frame
Start Date: 2024-01-23
Estimated Completion Date: 2025-05-01
Participants
Target number of participants: 88
Treatments
Experimental: Genotype guided P2Y12 monotherapy
Patients will be tested for the CYP2C19 genotype. Patients without a loss-of-function (LOF) allele will receive clopidogrel monotherapy (tablet of 75mg once daily) for 6 months. Patients with a LOF-allel will receive ticagrelor (tablet of 90mg twice daily) or prasugrel (tablet of 10mg once daily) for 6 months.
Active_comparator: Standard DAPT
Patients will receive clopidogrel monotherapy (tablet of 75mg once daily) for 6 months and acetylsalicylic acid (tablet 80mg one daily) for 6 months.
Sponsors
Leads: St. Antonius Hospital

This content was sourced from clinicaltrials.gov