[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100512662":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":36,"centralContacts":44,"locations":53,"responsibleParty":281,"collaborators":283,"id":287,"slug":288,"hasResults":289,"nctId":290,"briefTitle":291,"officialTitle":292,"acronym":293,"eligibilityCriteria":294,"healthyVolunteers":289,"sex":295,"minAge":296,"maxAge":27,"enrollmentInfo":297,"targetDuration":27,"studyType":300,"phases":301,"briefSummary":303,"conditions":304,"keywords":27,"overallStatus":190,"whyStopped":27,"lastUpdateSubmitDate":309,"lastUpdatePostDateStruct":310,"startDateStruct":313,"completionDateStruct":315,"leadSponsor":317,"locationsCount":318},{"fullName":5,"class":6},"Insel Gruppe AG, University Hospital Bern","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Monotherapy strategy","EXPERIMENTAL","Patients randomized to the monotherapy treatment arm receive any of the commercially available oral P2Y12 inhibitors (clopidogrel, prasugrel oder ticagrelor) and immediately discontinue aspirin and DOAC (or will not re-start DOAC after PCI if treatment was temporarily stopped before). After 1 month, the P2Y12 inhibitor will be stopped and treatment with a commercially available DOAC (at investigator's discretion and dosed according to the instructions for use in patients with atrial fibrillation) will be initiated for the duration of 11 months. After completion of the 12-month study regimen (study visit), the patient will receive antithrombotic therapy according to routine care.",[13,14],"Drug: P2Y12 inhibitor","Drug: DOAC",{"label":16,"type":17,"description":18,"interventionNames":19},"Standard of care strategy","ACTIVE_COMPARATOR","Patients randomized to the standard of care, receive DOAC for at least 12 months. In addition, aspirin is administered for up to 1 month after PCI at investigator's discretion and one of the available P2Y12 inhibitors (clopidogrel, prasugrel oder ticagrelor at investigator's discretion) is administered for a minimum of 6 months and up to 12 months after PCI. After completion of the 12-month control arm regimen (study visit), the patients will be treated according to routine care.",[13,20,14],"Drug: Aspirin",[22,28,32],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","P2Y12 inhibitor","The choice of P2Y12 inhibitor is left at investigator's discretion.",[9,16],null,{"type":23,"name":29,"description":30,"armGroupLabels":31,"otherNames":27},"Aspirin","Aspirin is administered for up to 1 month after PCI at investigator's discretion",[16],{"type":23,"name":33,"description":34,"armGroupLabels":35,"otherNames":27},"DOAC","The choice of DOAC is left at investigator's discretion.",[9,16],[37,41],{"name":38,"affiliation":39,"role":40},"Stephan Windecker, Prof","Bern University Hospital, Department of Cardiology","PRINCIPAL_INVESTIGATOR",{"name":42,"affiliation":43,"role":40},"Marco Valgimigli, Prof","Cardiocentro Ticino Institute",[45,50],{"name":46,"role":47,"phone":48,"phoneExt":27,"email":49},"Stephan Windecker, Prof.","CONTACT","+41 31 632 44 97","Stephan.Windecker@insel.ch",{"name":42,"role":47,"phone":51,"phoneExt":27,"email":52},"+41 91 805 31 11","Marco.Valgimigli@eoc.ch",[54,71,86,101,114,130,144,159,174,189,206,222,238,252,266],{"facility":55,"status":56,"city":57,"state":27,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"Hartcentrum Hasselt","NOT_YET_RECRUITING","Hasselt","3500","Belgium","BE",{"type":62,"coordinates":63},"Point",[64,65],5.33781,50.93106,{"lat":65,"lon":64},[68],{"name":69,"role":47,"phone":27,"phoneExt":27,"email":70},"Pascal Vranckx, Prof","pascal.vranckx@jessazh.be",{"facility":72,"status":56,"city":73,"state":27,"zip":74,"country":75,"countryCode":76,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"CHU Nîmes","Nîmes","30029","France","FR",{"type":62,"coordinates":78},[79,80],4.35788,43.83665,{"lat":80,"lon":79},[83],{"name":84,"role":47,"phone":27,"phoneExt":27,"email":85},"Guillaume Cayla, Prof","cayla.guillaume@gmail.com",{"facility":87,"status":56,"city":88,"state":27,"zip":89,"country":90,"countryCode":91,"cosmosGeoPoint":92,"geoPoint":96,"contacts":97},"Universitätsklinikum Frankfurt\u002FMain","Frankfurt am Main","60590","Germany","DE",{"type":62,"coordinates":93},[94,95],8.68417,50.11552,{"lat":95,"lon":94},[98],{"name":99,"role":47,"phone":27,"phoneExt":27,"email":100},"David M. Leistner, Prof","david.leistner@kgu.de",{"facility":102,"status":56,"city":103,"state":27,"zip":104,"country":90,"countryCode":91,"cosmosGeoPoint":105,"geoPoint":109,"contacts":110},"Klinikum Friedrichshafen","Friedrichshafen","88048",{"type":62,"coordinates":106},[107,108],9.47554,47.65689,{"lat":108,"lon":107},[111],{"name":112,"role":47,"phone":27,"phoneExt":27,"email":113},"Julia Seeger, Priv.-Doz.","seeger.julia@medizincampus.de",{"facility":115,"status":56,"city":116,"state":117,"zip":118,"country":119,"countryCode":120,"cosmosGeoPoint":121,"geoPoint":125,"contacts":126},"Ospedale Ferrarotto","Catania","Catania CT","95124","Italy","IT",{"type":62,"coordinates":122},[123,124],15.07041,37.49223,{"lat":124,"lon":123},[127],{"name":128,"role":47,"phone":27,"phoneExt":27,"email":129},"Davide F.M. Capodanno, Prof","dcapodanno@gmail.com",{"facility":131,"status":56,"city":132,"state":133,"zip":134,"country":119,"countryCode":120,"cosmosGeoPoint":135,"geoPoint":139,"contacts":140},"IRCCS Humanitas","Milan","Rozzano","20089",{"type":62,"coordinates":136},[137,138],12.59836,42.78235,{"lat":138,"lon":137},[141],{"name":142,"role":47,"phone":27,"phoneExt":27,"email":143},"Giulio Stefanini, Prof","giulio.stefanini@hunimed.eu",{"facility":145,"status":56,"city":146,"state":27,"zip":147,"country":148,"countryCode":149,"cosmosGeoPoint":150,"geoPoint":154,"contacts":155},"UMC public","Amsterdam","1081","Netherlands","NL",{"type":62,"coordinates":151},[152,153],4.88969,52.37403,{"lat":153,"lon":152},[156],{"name":157,"role":47,"phone":27,"phoneExt":27,"email":158},"Joanna J. Wykrzykowska, PhD","j.j.wykrzykowska@umcg.nl",{"facility":160,"status":56,"city":161,"state":27,"zip":162,"country":163,"countryCode":164,"cosmosGeoPoint":165,"geoPoint":169,"contacts":170},"Uniwersytet Medyczny im. Karola Marcinkowskiego w Poznaniu","Poznan","61-701","Poland","PL",{"type":62,"coordinates":166},[167,168],16.92993,52.40692,{"lat":168,"lon":167},[171],{"name":172,"role":47,"phone":27,"phoneExt":27,"email":173},"Maciej Lesiak, Prof","maciej.lesiak@skpp.edu.pl",{"facility":175,"status":56,"city":176,"state":27,"zip":177,"country":178,"countryCode":179,"cosmosGeoPoint":180,"geoPoint":184,"contacts":185},"Hospital Universitario Marques de Valdecilla","Santander","39008","Spain","ES",{"type":62,"coordinates":181},[182,183],-3.80493,43.46589,{"lat":183,"lon":182},[186],{"name":187,"role":47,"phone":27,"phoneExt":27,"email":188},"Josè M. De La Torre Hernandez, MD","josemariadela.torre@scsalud.es",{"facility":43,"status":190,"city":191,"state":192,"zip":193,"country":194,"countryCode":195,"cosmosGeoPoint":196,"geoPoint":200,"contacts":201},"RECRUITING","Lugano","Canton Ticino","6900","Switzerland","CH",{"type":62,"coordinates":197},[198,199],8.96004,46.01008,{"lat":199,"lon":198},[202,203],{"name":42,"role":47,"phone":51,"phoneExt":27,"email":52},{"name":204,"role":47,"phone":27,"phoneExt":27,"email":205},"Daniel Sürder, MD","daniel.suerder@eoc.ch",{"facility":207,"status":190,"city":208,"state":27,"zip":209,"country":194,"countryCode":195,"cosmosGeoPoint":210,"geoPoint":214,"contacts":215},"Universitätsspital Basel","Basel","4031",{"type":62,"coordinates":211},[212,213],7.57327,47.55839,{"lat":213,"lon":212},[216,219],{"name":217,"role":47,"phone":27,"phoneExt":27,"email":218},"Christoph Kaiser, Prof","christoph.kaiser@usb.ch",{"name":220,"role":47,"phone":27,"phoneExt":27,"email":221},"Gregor Leibundgut, Prof","gregor.leibundgut@usb.ch",{"facility":223,"status":190,"city":224,"state":27,"zip":225,"country":194,"countryCode":195,"cosmosGeoPoint":226,"geoPoint":230,"contacts":231},"Inselspital, Bern University Hospital, Department of Cardiology","Bern","3010",{"type":62,"coordinates":227},[228,229],7.44744,46.94809,{"lat":229,"lon":228},[232,234],{"name":38,"role":47,"phone":233,"phoneExt":27,"email":49},"+41 31 63 2 44 97",{"name":235,"role":47,"phone":236,"phoneExt":27,"email":237},"André Frenk, PhD","+ 41 31 632 19 16","andre.frenk@insel.ch",{"facility":239,"status":190,"city":240,"state":27,"zip":241,"country":194,"countryCode":195,"cosmosGeoPoint":242,"geoPoint":246,"contacts":247},"Hôpitaux Universitaires de Genève","Geneva","1211",{"type":62,"coordinates":243},[244,245],6.14569,46.20222,{"lat":245,"lon":244},[248],{"name":249,"role":47,"phone":250,"phoneExt":27,"email":251},"Marco Roffi, Prof","+41 22 372 75 31","marco.roffi@hcuge.ch",{"facility":253,"status":190,"city":254,"state":27,"zip":255,"country":194,"countryCode":195,"cosmosGeoPoint":256,"geoPoint":260,"contacts":261},"University Hospital Zürich","Zurich","8091",{"type":62,"coordinates":257},[258,259],8.55,47.36667,{"lat":259,"lon":258},[262],{"name":263,"role":47,"phone":264,"phoneExt":27,"email":265},"Barbara Elisabeth Stähli, Prof","0041 43 253 05 97","barbara.staehli@usz.ch",{"facility":267,"status":56,"city":268,"state":27,"zip":269,"country":270,"countryCode":271,"cosmosGeoPoint":272,"geoPoint":276,"contacts":277},"Imperial College London","London","SW7 2AZ","United Kingdom","UK",{"type":62,"coordinates":273},[274,275],-0.12574,51.50853,{"lat":275,"lon":274},[278],{"name":279,"role":47,"phone":27,"phoneExt":27,"email":280},"Diana Gorog, Prof","d.gorog@imperial.ac.uk",{"type":282,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR",[284],{"name":285,"class":286},"Sahajanand Medical Technologies Limited","INDUSTRY","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":298,"type":299},3010,"ESTIMATED","INTERVENTIONAL",[302],"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\").",[305,306,307,308],"Percutaneous Coronary Intervention (PCI)","Atrial Fibrillation (AF)","Oral Anticoagulation","P2Y12 Inhibitor","2026-05-07",{"date":311,"type":312},"2026-05-08","ACTUAL",{"date":314,"type":312},"2023-12-18",{"date":316,"type":299},"2028-06-30",{"name":5,"class":6},15]