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

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.

Eligibility

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

Conditions7

Interventions3

Related trials

• Anti-platelet Effect of Berberine in Patients After Percutaneous Coronary Intervention — Peking Union Medical College Hospital
• Clopidogrel Versus Cilostazol on Vessels — Seoul National University Bundang Hospital
• Efficacy and Safety Study of Vicagrel in Patients With Acute Coronary Syndrome (ACS) Undergoing Percutaneous Coronary Intervention (PCI) — Jiangsu vcare pharmaceutical technology co., LTD
• POPular GUILTY PILOT: Genotype-guided Clopidogrel Monotherapy — St. Antonius Hospital
• Dual Antiplatelet Therapy Escalation From Standard-dose Clopidogrel to Low-Dose Prasugrel in Patients With High Bleeding and Ischemic Risk Undergoing PCI: A Prospective, Randomized Pharmacodynamic Study (TAILOR-BLEED-2) — University of Florida
• Effects of Low-dose Ticagrelor vs. Clopidogrel in Stable Patients Undergoing Elective Percutaneous Coronary Intervention — University of Florida
• IndObufen Versus asPirin After Coronary Drug-eluting Stent implantaTION in Elderly Patients With Acute Coronary Syndrome — Shanghai Zhongshan Hospital
• SAPT Versus DAPT in Incomplete Revascularization After CABG — Campus Bio-Medico University

Browse More Trials