Long-term P2Y12 inhibitor monotherapy and blood clotting after angioplasty

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

HI-TECH 2 is a prospective, single-center, open-label, two-phase study that aims to optimize long-term P2Y12 inhibitor monotherapy after percutaneous coronary intervention. In Phase 1, enrolled patients undergo stepwise dose reductions of ticagrelor and prasugrel with within-subject pharmacodynamic assessment using serial platelet function tests (VerifyNow and Multiplate) at steady state. Phase 2 applies the findings to select long-term monotherapy regimens and characterizes coagulation activity over time. The trial enrolls adults who are ≥3 months post-ACS or PCI, have completed an uneventful DAPT course, and are eligible for P2Y12 monotherapy.

Why it matters

Who can join: the full rules

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

Where it's running

• Istituto Cardiocentro Ticino
  Lugano, Ch/ti, Switzerland Recruiting

Study contacts

• Principal investigator: Marco Valgimigli, Cardiology Chief Prof. Dr. Med — Cardiocentro Ticino
• Study coordinator: Marco Valgimigli, Cardiology Chief Prof. Dr. Med
• Email: marco.valgimigli@eoc.ch
• Phone: +41 (0) 91 811 51 11

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.