Long-term P2Y12 inhibitor monotherapy and blood clotting after angioplasty
Hunting for the Long-Term EffeCts of P2Y12 Inhibitor monotHerapy and Coagulation Monitoring After PCI: an Open-label, Randomized Study.
This trial will test whether specific P2Y12 drugs and reduced doses given alone keep platelet activity in a safe therapeutic range for people who completed initial dual antiplatelet therapy after PCI.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 355 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cardiocentro Ticino Academic / other |
| Locations | 1 site (Lugano, Ch/ti) |
| Trial ID | NCT07582835 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18 years) at least 3 months after ACS and/or PCI who completed an uneventful course of dual antiplatelet therapy and are eligible for single P2Y12 inhibitor monotherapy without recent ischemic or bleeding events may qualify.
Not a fit: People who need concomitant oral anticoagulation, have severe hepatic impairment, active bleeding risk, very low hemoglobin or platelets, are pregnant, or have life expectancy under one year are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the study could enable more personalized P2Y12 monotherapy that balances bleeding and clotting risk by identifying optimal drug and dose strategies.
How similar studies have performed: Previous large trials have shown that switching to P2Y12 monotherapy after short DAPT can reduce bleeding without clearly increasing ischemic events, but systematic stepwise dose reduction to target a predefined platelet reactivity window is a relatively novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Lugano, Ch/ti
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.