[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"protein-kinase-inhibitors\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:protein-kinase-inhibitors":39},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,75],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":51,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":74},"100557242","single-vs-dual-antiplatelet-therapy-in-elderly-or-hbr-patients-undergoing-percutaneous-intervention-with-dcb-piccoleto-iv-epic-38-100557242",false,"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.","ALL",{"count":19,"type":20},576,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50],"Coronary Disease","Heart Diseases","Cardiovascular Diseases","Myocardial Ischemia","Atherosclerosis","Arterial Occlusive Diseases","Vascular Diseases","Coronary Artery Disease","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","Single Antiplatelet Therapy","Dual Antiplatelet Therapy","Cyclooxygenase Inhibitors","P2Y12 Inhibitor","Platelet Aggregation Inhibitors","Aspirin","Clopidogrel",[52,53,54,55,56,57,58,59,60,61],"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","RECRUITING","2026-01-21",{"date":65,"type":66},"2026-01-22","ACTUAL",{"date":68,"type":66},"2026-01-10",{"date":70,"type":20},"2028-02-20",{"name":72,"class":73},"Fondazione Ricerca e Innovazione Cardiovascolare ETS","OTHER",1,{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":17,"minAge":83,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":21,"phases":86,"briefSummary":88,"conditions":89,"keywords":93,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":74},"100525931","phase-1-phase-i-study-of-jyp0322-in-ros1-fusion-positive-solid-tumors-100525931","NCT06128148","Phase I Study of JYP0322 in ROS1 Fusion-Positive Solid Tumors","A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of JYP0322 in Patients With Solid Tumors","JYP0322","Key Inclusion Criteria\n\n* Adult patients age 18 years or older.\n* Histologically or cytologically confirmed diagnosis of locally advanced or metastatic solid tumors that have a ROS1 molecular fusion.\n* Measurable disease according to RECIST version 1.1\n* Life expectancy of at least 3 months\n* Other protocol specified criteria\n\nKey Exclusion Criteria:\n\n* Current participation in another therapeutic clinical trial.\n* Gastrointestinal disease (e.g., Crohn's disease, ulcerative colitis, or short gut syndrome) or other malabsorption syndromes that would impact on drug absorption.\n* A history of severe allergies, or a history of severe allergy, hypersensitivity or other hypersensitivity to any active or inactive ingredient of the study drug.\n* Known active infections (bacterial, viral including HIV positivity).\n* Other protocol specified criteria","18 Years",{"count":85,"type":20},101,[87],"PHASE1","An open, non-randomized, multicenter, single-arm dose-escalation design, phase 1 trial to study the safety, tolerability, pharmacokinetics and efficacy of JYP0322 in patients with ROS1+ locally advanced\u002Fmetastatic solid tumors .",[39,90,91,92],"Other Protocol Specified Criteria","Lung Neoplasms","Brain Neoplasms",[94,95,96,97],"ROS1 Fusions","ROS1 Gene Rearrangements","Primary brain tumors","ROS1","2025-07-09",{"date":100,"type":66},"2025-07-14",{"date":102,"type":66},"2022-05-04",{"date":104,"type":20},"2027-12-30",{"name":106,"class":107},"Guangzhou JOYO Pharma Co., Ltd","INDUSTRY"]