Study of the Long-term Effects of P2Y12 Inhibitor Monotherapy and Coagulation Markers After Percu… (NCT07582835) | Clinical Trial Compass
RecruitingPhase 3
Study of the Long-term Effects of P2Y12 Inhibitor Monotherapy and Coagulation Markers After Percutaneous Coronary Angioplasty.
Switzerland355 participantsStarted 2026-04-20
Plain-language summary
Patients who undergo percutaneous coronary intervention (PCI) are commonly treated with antiplatelet therapy to prevent stent thrombosis and recurrence of events. After an initial period of dual antiplatelet therapy, long-term treatment with a single P2Y12 inhibitor (such as clopidogrel, ticagrelor, or prasugrel) is often prescribed. However, the optimal drug and dose for long-term monotherapy remain uncertain, as patients may experience either insufficient platelet inhibition (leading to ischemic events) or excessive inhibition (increasing bleeding risk).
The HI-TECH 2 study aims to identify the most appropriate type and dose of P2Y12 inhibitor monotherapy to achieve a balanced level of platelet inhibition within a predefined therapeutic range. The study also seeks to better understand how blood coagulation activity evolves over time after PCI.
This is a prospective, investigator-initiated, single-center, open-label study conducted in two phases. In Phase 1, patients receive stepwise reduced doses of ticagrelor or prasugrel to determine the optimal dose that most consistently achieves the desired level of platelet inhibition. In Phase 2, patients are randomly assigned to receive clopidogrel or the optimal doses of ticagrelor or prasugrel identified in Phase 1.
The main question of the study is whether optimized ticagrelor or prasugrel regimens are more effective than standard-dose clopidogrel in achieving platelet inhibition within the target therapeutic window, as measured by validated platelet function tests. Additional objectives include evaluating the role of genetic factors in treatment response and assessing markers of coagulation activation over time.
The results of this study may help personalize long-term antiplatelet therapy after PCI, improving the balance between reducing thrombotic risk and minimizing bleeding complications.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥18 years
* Prior (≥3 months) ACS and/or PCI
* Eligible for P2Y12 inhibitor monotherapy after an uneventful DAPT course
* Free from ischemic (i.e. any new episode of ACS, symptomatic restenosis, stent thrombosis, stroke, any revascularization requiring prolonged DAPT) and/or bleeding events (defined as BARC ≥ 2) for at least 3 months
* Written informed consent.
Exclusion Criteria:
* Unconscious patients
* Unable to provide written informed consent
* Under judicial protection, tutorship or curatorship
* Unable to understand and follow study-related instructions or unable to comply with study protocol
* Known hypersensitivity or allergy to clopidogrel, ticagrelor or prasugrel
* Severe hepatic impairment
* Haemoglobin level \<10 g/dL or platelet count \<100 000 cells/mL
* Pregnant or breastfeeding women
* Life expectancy less than 1 year
* Active participation in another interventional trial
* Need for concomitant oral anticoagulation
* History of intracranial haemorrhage (anytime), 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing whether lower doses of ticagrelor or prasugrel — used alone, without aspirin — can keep my platelets in a safe range after a stent procedure; is that approach considered safe enough for someone in my specific situation, given that the trial is still in Phase 3 and full safety data aren't yet available?
2The trial measures platelet reactivity using a test called VerifyNow at 3 months after starting the assigned treatment — does my current care plan already involve that kind of monitoring, and would switching to a trial regimen disrupt the antiplatelet therapy you've already recommended for me?
3Since this study involves patients who've had coronary angioplasty, including those with acute coronary syndromes, would you consider my recent procedure and diagnosis stable enough to even discuss a trial like this, or would standard dual antiplatelet therapy be a safer first step for me right now?
4The trial is comparing single antiplatelet therapy at reduced doses against what's typically a two-drug regimen after a stent — what would happen to my bleeding risk and clot risk if I were on a lower dose of just one of these medications instead of the current standard approach?
5If I enrolled and the VerifyNow test at 3 months showed my platelet reactivity was outside the target window, what would my options be — would I be switched back to standard therapy, or would I stay on the trial regimen?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Identification of reduced doses of ticagrelor and prasugrel achieving target platelet reactivity by VerifyNow (Phase 1)
Timeframe: During the dose-finding phase (Phase 1): at baseline and at Visit 1 (at approximately 30 days), Visit 2 (at approximately 60 days), and Visit 3 (at approximately 90 days).
2
Proportion of patients achieving platelet reactivity within the therapeutic window by VerifyNow at 3 months after randomization (Phase 2)