Actively Recruiting
Hunting for the Long-Term Effects of P2Y12 Inhibitor Monotherapy and Coagulation Monitoring After PCI: an Open-label, Randomized Study
Led by Cardiocentro Ticino · Updated on 2026-05-13
355
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying patients who have undergone percutaneous coronary intervention (PCI) and are receiving long-term monotherapy with P2Y12 inhibitors like clopidogrel, ticagrelor, or prasugrel to prevent blood clots and recurrence of heart events. This study aims to find the best type and dose of P2Y12 inhibitor that achieves balanced platelet inhibition to reduce risks of both clotting and bleeding. The trial also investigates how blood clotting activity changes over time after PCI. The study is divided into two phases. In Phase 1, patients receive gradually reduced doses of ticagrelor or prasugrel to find the optimal dose that keeps platelet activity in a target range. In Phase 2, patients are randomly assigned to receive either standard-dose clopidogrel or the optimized doses of ticagrelor or prasugrel identified in Phase 1. The study includes platelet function tests and blood biomarker analysis to assess clotting activity. Participants will undergo regular platelet function testing at about 30, 60, and 90 days during Phase 1, then after randomization in Phase 2 at 3 and 6 months. Genetic testing is also done to explore how genes affect treatment response. Safety and drug adherence are monitored up to 6 months. The study outcome focuses on how well patients maintain platelet reactivity within the therapeutic window and examines markers of clotting and bleeding events over time.
CONDITIONS
Brief Title
Study of the Long-term Effects of P2Y12 Inhibitor Monotherapy and Coagulation Markers After Percutaneous Coronary Angioplasty.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- History of acute coronary syndrome and/or PCI at least 3 months prior
- Eligible for P2Y12 inhibitor monotherapy after completing dual antiplatelet therapy without complications
- No ischemic or bleeding events (BARC 2) for at least 3 months
- Provided written informed consent
You will not qualify if you...
- Unconscious or unable to provide written informed consent
- Under judicial protection, tutorship, or curatorship
- Unable to understand or follow study instructions or protocol
- Known allergy to clopidogrel, ticagrelor, or prasugrel
- Severe liver impairment
- Hemoglobin below 10 g/dL or platelet count below 100,000 cells/mL
- Pregnant or breastfeeding women
- Life expectancy less than 1 year
- Currently participating in another interventional trial
- Need for oral anticoagulation
- History of intracranial hemorrhage, transient ischemic attack, or stroke within 3 months
- PCI for in-stent restenosis or stent thrombosis at index PCI or within 6 months before randomization
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 3 months
Participants undergo stepwise dose reductions of ticagrelor and prasugrel with serial platelet function testing to identify optimized doses achieving platelet reactivity within a therapeutic window.
4 visits (baseline and at approximately 30, 60, and 90 days)
Duration - 6 months
Participants are randomized to receive clopidogrel, ticagrelor, or prasugrel monotherapy at optimized doses following completion of dual antiplatelet therapy after PCI.
Multiple visits including baseline, 3 months, and 6 months after randomization with additional visits at 3 to 6 hours post-loading dose and 1 to 2 hours post-maintenance dose
Duration - Up to 6 months after randomization
Participants are monitored for clinical outcomes, drug adherence, tolerability, platelet reactivity, coagulation biomarkers, and pharmacogenetic correlations following treatment.
Approximately 3 visits during treatment phase plus additional assessments as scheduled
Trial Site Locations
Total: 1 location
1
Istituto Cardiocentro Ticino
Lugano, Ch/ti, Switzerland, 6900
Actively Recruiting
Research Team
M
Marco Valgimigli, Cardiology Chief Prof. Dr. Med
E
Enrico Frigoli, Dr. Med
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here