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Study of the Long-term Effects of P2Y12 Inhibitor Monotherapy and Coagulation Markers After Percutaneous Coronary Angioplasty.

RecruitingPhase 3Ages 18 Years - anyAllCardiocentro Ticino
NCT07582835 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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-init

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📋 Eligibility rules (as published)
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
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What it tests

  • Clopidogrel
  • Ticagrelor
  • Prasugrel
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Where

1 site
Istituto Cardiocentro Ticino
Lugano, Switzerland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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