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

Sponsor
Cardiocentro Ticino
Study ID
NCT07582835
Phase
PHASE3
Status
Recruiting
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Conditions

  • Acute Coronary Syndromes
  • Antiplatelet Therapy
  • Coagulation Factors
  • Coronary Artery Disease
  • Percutaneous Coronary Intervention
  • Single Antiplatelet Therapy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Clopidogrel — DRUG
    Clopidogrel 75 mg once daily administered as maintenance P2Y12 inhibitor monotherapy following completion of dual antiplatelet therapy after PCI. This regimen represents the standard comparator arm in the study.
  • Ticagrelor — DRUG
    Ticagrelor monotherapy administered at the optimized maintenance dose identified in Phase 1 dose-finding stage. Dose selection is based on stepwise dose reduction with serial platelet function testing (VerifyNow P2Y12 and Multiplate) to achieve platelet reactivity within the predefined therapeutic window. Administered after completion of dual antiplatelet therapy following PCI.
  • Prasugrel — DRUG
    Prasugrel monotherapy administered at the optimized maintenance dose identified in Phase 1 dose-finding stage. Dose selection is based on stepwise dose reduction with serial platelet function testing (VerifyNow P2Y12 and Multiplate) to achieve platelet reactivity within the predefined therapeutic window. Administered after completion of dual antiplatelet therapy following PCI.

Study Details

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.

Key Dates

First listed
May 13, 2026
Start date
Apr 20, 2026
Status verified
Apr 2026
Primary completion
Apr 30, 2028
Completion
Apr 30, 2028

Study Design

Enrollment
355 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Clopidogrel Monotherapy (Standard Dose) (Phase 2)
    Participants receive clopidogrel 75 mg once daily as standard-dose P2Y12 inhibitor monotherapy after completion of dual antiplatelet therapy following PCI.
  • Experimental: Ticagrelor Monotherapy (Optimized Dose) (Phase 2)
    Participants receive ticagrelor monotherapy at the optimized maintenance dose identified in Phase 1 of the study after discontinuation of dual antiplatelet therapy following PCI. Dose selection is based on prior dose-finding platelet function testing.
  • Experimental: Prasugrel Monotherapy (Optimized Dose) (Phase 2)
    Participants receive prasugrel monotherapy at the optimized maintenance dose identified in Phase 1 of the study after discontinuation of dual antiplatelet therapy following PCI. Dose selection is based on prior dose-finding platelet function testing.

Primary Outcome Measure

Identification of reduced doses of ticagrelor and prasugrel achieving target platelet reactivity by VerifyNow (Phase 1) [ Time Frame: 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). ]

Central Contacts

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