[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100638421":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":45,"centralContacts":49,"locations":59,"responsibleParty":78,"collaborators":53,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":83,"sex":89,"minAge":90,"maxAge":53,"enrollmentInfo":91,"targetDuration":53,"studyType":94,"phases":95,"briefSummary":97,"conditions":98,"keywords":105,"overallStatus":62,"whyStopped":53,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":137},{"fullName":5,"class":6},"Cardiocentro Ticino","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Clopidogrel Monotherapy (Standard Dose) (Phase 2)","ACTIVE_COMPARATOR","Participants receive clopidogrel 75 mg once daily as standard-dose P2Y12 inhibitor monotherapy after completion of dual antiplatelet therapy following PCI.",[13],"Drug: Clopidogrel",{"label":15,"type":16,"description":17,"interventionNames":18},"Ticagrelor Monotherapy (Optimized Dose) (Phase 2)","EXPERIMENTAL","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.",[19],"Drug: Ticagrelor",{"label":21,"type":16,"description":22,"interventionNames":23},"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.",[24],"Drug: Prasugrel",[26,33,39],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DRUG","Clopidogrel","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.",[9],[32],"Plavix",{"type":27,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"Ticagrelor","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.",[15],[38],"Brilique",{"type":27,"name":40,"description":41,"armGroupLabels":42,"otherNames":43},"Prasugrel","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.",[21],[44],"Efient",[46],{"name":47,"affiliation":5,"role":48},"Marco Valgimigli, Cardiology Chief Prof. Dr. Med","PRINCIPAL_INVESTIGATOR",[50,55],{"name":47,"role":51,"phone":52,"phoneExt":53,"email":54},"CONTACT","+41 (0) 91 811 51 11",null,"marco.valgimigli@eoc.ch",{"name":56,"role":51,"phone":57,"phoneExt":53,"email":58},"Enrico Frigoli, Dr. Med","+41 (0)91 811 53 04","enrico.frigoli@eoc.ch",[60],{"facility":61,"status":62,"city":63,"state":64,"zip":65,"country":66,"countryCode":67,"cosmosGeoPoint":68,"geoPoint":73,"contacts":74},"Istituto Cardiocentro Ticino","RECRUITING","Lugano","Ch\u002Fti","6900","Switzerland","CH",{"type":69,"coordinates":70},"Point",[71,72],8.96004,46.01008,{"lat":72,"lon":71},[75],{"name":76,"role":51,"phone":53,"phoneExt":53,"email":77},"Servizio di Ricerca Cardiovascolare Cardiocentro, +41 (0)91 811 53 04","src.ICCT@eoc.ch",{"type":48,"investigatorFullName":79,"investigatorTitle":80,"investigatorAffiliation":5,"oldNameTitle":53,"oldOrganization":53},"Marco Valgimigli","Cardiology Chief Prof. Dr. Med","100638421","phase-3-study-of-the-long-term-effects-of-p2y12-inhibitor-monotherapy-and-coagulation-markers-after-percutaneous-coronary-angioplasty-100638421",false,"NCT07582835","Study of the Long-term Effects of P2Y12 Inhibitor Monotherapy and Coagulation Markers After Percutaneous Coronary Angioplasty.","Hunting for the Long-Term EffeCts of P2Y12 Inhibitor monotHerapy and Coagulation Monitoring After PCI: an Open-label, Randomized Study.","HI-TECH 2","Inclusion Criteria:\n\n* Age ≥18 years\n* Prior (≥3 months) ACS and\u002For PCI\n* Eligible for P2Y12 inhibitor monotherapy after an uneventful DAPT course\n* Free from ischemic (i.e. any new episode of ACS, symptomatic restenosis, stent thrombosis, stroke, any revascularization requiring prolonged DAPT) and\u002For bleeding events (defined as BARC ≥ 2) for at least 3 months\n* Written informed consent.\n\nExclusion Criteria:\n\n* Unconscious patients\n* Unable to provide written informed consent\n* Under judicial protection, tutorship or curatorship\n* Unable to understand and follow study-related instructions or unable to comply with study protocol\n* Known hypersensitivity or allergy to clopidogrel, ticagrelor or prasugrel\n* Severe hepatic impairment\n* Haemoglobin level \\\u003C10 g\u002FdL or platelet count \\\u003C100 000 cells\u002FmL\n* Pregnant or breastfeeding women\n* Life expectancy less than 1 year\n* Active participation in another interventional trial\n* Need for concomitant oral anticoagulation\n* History of intracranial haemorrhage (anytime), transient ischemic attack or stroke within 3 months\n* PCI for in-stent restenosis or stent thrombosis at index PCI or within 6 months before randomization","ALL","18 Years",{"count":92,"type":93},355,"ESTIMATED","INTERVENTIONAL",[96],"PHASE3","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).\n\nThe 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.\n\nThis 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.\n\nThe 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.\n\nThe results of this study may help personalize long-term antiplatelet therapy after PCI, improving the balance between reducing thrombotic risk and minimizing bleeding complications.",[99,100,101,102,103,104],"Coronary Artery Disease","Percutaneous Coronary Intervention","Acute Coronary Syndromes","Antiplatelet Therapy","Single Antiplatelet Therapy","Coagulation Factors",[99,103,106,34,40,107,28,108,109,110,111,101,112,113,114,115,116,117,118,119,120,121,122,123,124,125,126,127],"Antiplatelet therapy","Coagulation biomarkers","Multiplate","VerifyNow","CYP2C19","ABCB1 gene","Dose optimization","platelet function tests (PFT)","Percutaneous Coronary Intervention (PCI)","High platelet reactivity (HPR)","Low platelet reactivity (LPR)","Bleeding Risk","Ischemic risk","prothrombin fragment F1+2","thrombin-antithrombin (TAT) complex","fibrinopeptide A","fibrinogen","D-dimer","von Willebrand factor activity (VWF)","plasminogen activator inhibitor-1 (PAI-1)","thrombin-activatable fibrinolysis inhibitor (TAFI)","circulating extracellular vesicles","2026-05-06",{"date":130,"type":131},"2026-05-13","ACTUAL",{"date":133,"type":93},"2026-04-20",{"date":135,"type":93},"2028-04",{"name":5,"class":6},1]