[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"single-antiplatelet-therapy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:single-antiplatelet-therapy":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,72],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":33,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":71},"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":20,"type":21},355,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28,29,30,31,32],"Coronary Artery Disease","Percutaneous Coronary Intervention","Acute Coronary Syndromes","Antiplatelet Therapy","Single Antiplatelet Therapy","Coagulation Factors",[27,31,34,35,36,37,38,39,40,41,42,29,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58],"Antiplatelet therapy","Ticagrelor","Prasugrel","Coagulation biomarkers","Clopidogrel","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","RECRUITING","2026-05-06",{"date":62,"type":63},"2026-05-13","ACTUAL",{"date":65,"type":21},"2026-04-20",{"date":67,"type":21},"2028-04",{"name":69,"class":70},"Cardiocentro Ticino","OTHER",1,{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":22,"phases":82,"briefSummary":84,"conditions":85,"keywords":108,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":71},"100557242","single-vs-dual-antiplatelet-therapy-in-elderly-or-hbr-patients-undergoing-percutaneous-intervention-with-dcb-piccoleto-iv-epic-38-100557242","NCT06535568","Single vs. Dual Antiplatelet Therapy in Elderly or HBR Patients Undergoing Percutaneous Intervention With DCB (PICCOLETO IV-EPIC 38)","International, Multicenter, Investigator-driven Randomized Clinical Trial to Assess the Single vs. Dual Antiplatelet Therapy in Elderly or HBR Patients Undergoing Percutaneous Intervention With Drug-coated Balloons (PICCOLETO IV-EPIC 38)","PIV-EPIC","Inclusion Criteria:\n\nMale and female patients who meet the following criteria:\n\n* Age ≥ 75 years or age ≥ 18 years at high bleeding risk;\n* Successful PCI with Essential Pro DCB just performed, in 1, 2 or 3 coronary vessels;\n* Stable or unstable coronary syndromes;\n* De novo coronary lesions in vessels with diameter ≥2.0 and ≤4.0 mm (visual estimation);\n* Informed consent to participate in the study given by the patient or impartial witness.\n\nExclusion Criteria:\n\n* Stent implantation during index or recent (\\\u003C6 months) procedure;\n* Known (and untreatable) hypersensitivity or contraindication to aspirin, heparin, clopidogrel, paclitaxel or contrast media, or any of their excipient which cannot be adequately pre-medicated;\n* Pregnancy at the time of hospitalization;\n* Patients participating in another clinical study in which an investigational drug or device was administered within 30 days of screening or within the 5 half-lives of the study drug, whichever is longer;\n* ST-elevation myocardial infarction;\n* Life expectancy \\\u003C12 months;\n* Left ventricular ejection fraction \\\u003C30%;\n* Visible thrombus at lesion site;\n* Target lesion\u002Fvessel with any of the following characteristics:\n\n  * severe and\u002For \\>270° calcification of the target vessel, also proximal to the lesion (intravascular imaging not mandatory);\n  * left main stem stenosis \\>50%;\n  * target lesion is in the left main stem;\n  * chronic total occlusion with anticipated necessity of retrograde approach;\n  * lesion is in a bypass graft.\n* History of asthma induced by the administration of salicylates or substances with a similar action, notably non-steroidal anti-inflammatory medicines (NSAIDs);\n* History of gastrointestinal perforation, ulceration, or bleeding (peptic ulcer bleeding-PUBs) related to previous use of NSAIDs or anticoagulant medications, or intracranial hemorrhage;\n* Acute gastrointestinal ulcers;\n* Hemorrhagic diathesis (including known bleeding disorders or ongoing active bleeding);\n* Severe renal impairment (eGFR \\\u003C 30 mL\u002Fmin);\n* Severe hepatic impairment (Child-Pugh C), with elevated liver enzymes (ALT\u002FAST \\> 2 x ULN or total bilirubin \\>1.5 x ULN);\n* Severe cardiac failure (NYHA grade III or IV);\n* Combination with methotrexate at doses of 15 mg\u002Fweek or more;\n* Patients with baseline neutrophil counts \\\u003C 1500 cells\u002Fmm³;\n* Breastfeeding women;\n* Full-blown thyrotoxicosis;\n* Patients with a very high risk of thrombosis.",{"count":81,"type":21},576,[83],"NA","This international, multicenter, open-label, randomized clinical trial evaluates the safety and efficacy of single antiplatelet therapy (SAPT) compared to dual antiplatelet therapy (DAPT) in elderly or high bleeding risk patients undergoing percutaneous coronary intervention (PCI) with the latest generation drug-coated balloon (DCB). The study includes patients with stable or unstable coronary syndromes and aims to assess rates of ischemic and bleeding adverse events.",[86,87,88,89,90,91,92,27,93,94,95,96,97,98,99,100,101,102,31,103,104,105,106,107,38],"Coronary Disease","Heart Diseases","Cardiovascular Diseases","Myocardial Ischemia","Atherosclerosis","Arterial Occlusive Diseases","Vascular Diseases","Acute Coronary Syndrome","Coronary Stenosis","Molecular Mechanisms of Pharmacological Action","Enzyme Inhibitors","MTOR Inhibitors","Protein Kinase Inhibitors","Physiological Effects of Drugs","Immunosuppressive Agents","Antineoplastic Agents","High Bleeding Risk","Dual Antiplatelet Therapy","Cyclooxygenase Inhibitors","P2Y12 Inhibitor","Platelet Aggregation Inhibitors","Aspirin",[109,110,111,112,113,114,115,116,117,118],"DCB","Angioplasty","Paclitaxel","Antiplatelet treatment","Single antiplatelet therapy (SAPT)","Dual antiplatelet therapy (DAPT)","High bleeding risk (HBR)","MACE","Native CAD","stable or unstable coronary syndromes","2026-01-21",{"date":121,"type":63},"2026-01-22",{"date":123,"type":63},"2026-01-10",{"date":125,"type":21},"2028-02-20",{"name":127,"class":70},"Fondazione Ricerca e Innovazione Cardiovascolare ETS"]