[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"p2y12-inhibitor\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:p2y12-inhibitor":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"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":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100512662","phase-4-monotherapy-with-p2y12-inhibitors-in-patients-with-atrial-fibrillation-undergoing-supraflex-stent-implantation-100512662",false,"NCT05955365","Monotherapy With P2Y12 Inhibitors in Patients With Atrial fIbrillation Undergoing Supraflex Stent Implantation","Monotherapy With a P2Y12 Inhibitor Followed by a Direct-acting Oral Anticoagulant in Patients With ATRial fIbrillation Undergoing suprafleX Cruz Coronary Stent Implantation","MATRIX-2","Inclusion Criteria:\n\n* Age ≥18 years\n* Atrial fibrillation or flutter with an indication for oral anticoagulation using direct-acting oral anticoagulants (DOACs) for ≥12 months\n* Successful percutaneous coronary intervention in at least 1 lesion within the previous 7 days with no remaining lesions intended for treatment.\n* Free from major adverse events post qualifying PCI, including new onset chest pain suspected to be of ischemic origin, acute or subacute stent thrombosis, new-onset neurological signs or symptoms.\n* Written informed consent\n\nExclusion Criteria:\n\n* Planned staged percutaneous intervention procedure (Patients can be enrolled after complete coronary revascularization with no remaining lesions intended for treatment. Patients who have or develop indication to percutaneous valve intervention can undergo treatment more than 30 days after qualifying PCI.)\n* Cardioversion for treatment of atrial fibrillation within 1 month prior to inclusion or planned cardioversion\n* AF ablation procedure within 2 months prior to inclusion or planned AF ablation procedure\n* Prior mechanical valvular prosthesis implantation\n* Deep vein thrombosis\u002Fpulmonary embolism, at least moderately severe mitral stenosis or other clinical conditions than atrial fibrillation requiring long-term oral anticoagulation\n* Stroke within 1 month prior to randomization\n* Hemodynamic instability (persistent systolic blood pressure below 90 mmHg, continuous infusions of catecholamines, clinical signs of hypoperfusion and\u002For use of percutaneous left ventricular assist devices)\n* Uncontrolled severe hypertension with a systolic blood pressure (BP) ≥180 mmHg and\u002For diastolic BP ≥120 mmHg\n* Severe renal impairment with estimated creatinine clearance (CrCL) \\\u003C15 mL\u002Fmin or on dialysis\n* Moderate or severe hepatic impairment (Child-Pugh Class B or C) or any hepatic disease associated with coagulopathy\n* Any hypersensitivity or contraindications for direct oral anticoagulation or dual antiplatelet therapy with aspirin and a P2Y12 inhibitor\n* Any of the following abnormal local laboratory results prior to randomization: platelet count \\\u003C50 x109\u002FL or hemoglobin \\\u003C8 g\u002FdL\n* Known pregnancy or breast-feeding patients\n* Life expectancy \\\u003C1 year due to other severe non-cardiac disease\n* Planned surgery including coronary artery bypass grafting within the next 6 months","ALL","18 Years",{"count":20,"type":21},3010,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","Patients with atrial fibrillation undergoing percutaneous coronary intervention with stent implantation require treatment with different antithrombotic drugs. Oral anticoagulants are prescribed to reduce the risk of stroke associated with atrial fibrillation. Antiplatelet substances are prescribed after stent implantation to reduce the risk of adverse cardiac events such as myocardial infarction or stent thrombosis. Treatment with antithrombotic medications can cause bleeding complications, particularly when these substances are combined.\n\nThe currently recommended standard strategy consists of treatment with 3 antithrombotic medications for at least 1 week up to one month, followed by treatment with two of these medications for up to 6-12 months after stent implantation. Thereafter, patients usually receive long-term treatment with only one drug, an anticoagulant.\n\nIn the monotherapy group of this study, the investigators will investigate a strategy where only one antithrombotic drug will be used at a time. During the first month after stent implantation, the investigators will prescribe an antiplatelet medication, followed by an oral anticoagulant as monotherapy. This strategy might be associated with fewer bleeding complications, while protecting adequately against thrombotic events.\n\nIn this study the investigators would like to investigate whether treatment with a single antithrombotic drug (\"monotherapy strategy\") is associated with benefits compared to the currently recommended combination therapy of antithrombotic medications (\"standard-of-care strategy\").",[27,28,29,30],"Percutaneous Coronary Intervention (PCI)","Atrial Fibrillation (AF)","Oral Anticoagulation","P2Y12 Inhibitor","RECRUITING","2026-05-07",{"date":34,"type":35},"2026-05-08","ACTUAL",{"date":37,"type":35},"2023-12-18",{"date":39,"type":21},"2028-06-30",{"name":41,"class":42},"Insel Gruppe AG, University Hospital Bern","OTHER",15,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":56,"conditions":57,"keywords":82,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":102},"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":53,"type":21},576,[55],"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.",[58,59,60,61,62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,30,79,80,81],"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","Platelet Aggregation Inhibitors","Aspirin","Clopidogrel",[83,84,85,86,87,88,89,90,91,92],"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":95,"type":35},"2026-01-22",{"date":97,"type":35},"2026-01-10",{"date":99,"type":21},"2028-02-20",{"name":101,"class":42},"Fondazione Ricerca e Innovazione Cardiovascolare ETS",1]