[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100319988":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":47,"centralContacts":54,"locations":62,"responsibleParty":80,"collaborators":82,"id":86,"slug":87,"hasResults":88,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":92,"eligibilityCriteria":93,"healthyVolunteers":88,"sex":94,"minAge":95,"maxAge":34,"enrollmentInfo":96,"targetDuration":34,"studyType":99,"phases":100,"briefSummary":102,"conditions":103,"keywords":105,"overallStatus":65,"whyStopped":34,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"fullName":5,"class":6},"National Institute of Cardiology, Warsaw, Poland","OTHER",[8,14,19,24],{"label":9,"type":6,"description":10,"interventionNames":11},"30 days DAPT and long-term treatment with a single antiplatelet agent","short postimplantation dual antiplatelet therapy and long-term treatment with a single antiplatelet agent",[12,13],"Drug: short postimplantation dual antiplatelet therapy","Drug: long-term treatment with a single antiplatelet agent",{"label":15,"type":6,"description":16,"interventionNames":17},"6 months DAPT and long-term treatment with a single antiplatelet agent","extended postimplantation dual antiplatelet therapy and long-term treatment with a single antiplatelet agent",[18,13],"Drug: extended postimplantation dual antiplatelet therapy",{"label":20,"type":6,"description":21,"interventionNames":22},"30 days DAPT and 6 months treatment with a single antiplatelet agent","short postimplantation dual antiplatelet therapy and 6 months treatment with a single antiplatelet agent",[12,23],"Drug: 6 months treatment with a single antiplatelet agent",{"label":25,"type":6,"description":26,"interventionNames":27},"6 months DAPT and 6 months treatment with a single antiplatelet agent","extended postimplantation dual antiplatelet therapy and 6 months treatment with a single antiplatelet agent",[18,23],[29,35,39,43],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"DRUG","short postimplantation dual antiplatelet therapy","continuing dual antiplatelet therapy up until 6 months after left atrial appendage occlusion with Amplatzer or WATCHMAN device",[20,9],null,{"type":30,"name":36,"description":37,"armGroupLabels":38,"otherNames":34},"extended postimplantation dual antiplatelet therapy","stopping dual antiplatelet therapy after 30 days after left atrial appendage occlusion with Amplatzer or WATCHMAN device",[25,15],{"type":30,"name":40,"description":41,"armGroupLabels":42,"otherNames":34},"long-term treatment with a single antiplatelet agent","continuing long-term treatment with single antiplatelet agent",[9,15],{"type":30,"name":44,"description":45,"armGroupLabels":46,"otherNames":34},"6 months treatment with a single antiplatelet agent","continuing single antiplatelet agent up until 6 months",[20,25],[48,52],{"name":49,"affiliation":50,"role":51},"Radoslaw Pracon, MD PhD","Coronary and Structural Heart Diseases Department, National Institute of Cardiology, Warsaw, Poland","PRINCIPAL_INVESTIGATOR",{"name":53,"affiliation":50,"role":51},"Marcin Demkow, MD PhD",[55,60],{"name":49,"role":56,"phone":57,"phoneExt":58,"email":59},"CONTACT","22 343 43 42","+48","rpracon@ikard.pl",{"name":53,"role":56,"phone":57,"phoneExt":58,"email":61},"mdemkow@ikard.pl",[63],{"facility":64,"status":65,"city":66,"state":67,"zip":68,"country":69,"countryCode":70,"cosmosGeoPoint":71,"geoPoint":76,"contacts":77},"National Institute of Cardiology","RECRUITING","Warsaw","Masovian Voivodeship","04-628","Poland","PL",{"type":72,"coordinates":73},"Point",[74,75],21.01178,52.22977,{"lat":75,"lon":74},[78,79],{"name":49,"role":56,"phone":57,"phoneExt":58,"email":59},{"name":53,"role":56,"phone":57,"phoneExt":58,"email":61},{"type":81,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR",[83],{"name":84,"class":85},"Medical Research Agency, Poland","OTHER_GOV","100319988","phase-4-optimal-antiplatelet-therapy-following-left-atrial-appendage-closure-100319988",false,"NCT03445949","Optimal Antiplatelet Therapy Following Left Atrial Appendage Closure","Optimal Antiplatelet Treatment to Achieve Stroke Avoidance and Fall in Bleeding Events Following Left Atrial Appendage Closure (SAFE-LAAC). Comparative Health Effectiveness Randomized Trial - PILOT Study","SAFE-LAAC","Inclusion Criteria:\n\n* Successful left atrial appendage occlusion with Amplatzer or WATCHMAN device within 37 days before randomization\n* Treatment with dual antiplatelet therapy (clopidogrel and acetylsalicylic acid) between left atrial appendage closure and randomization\n* Participant's age 18 years or older at the time of signing the informed consent form\n* Participant is willing to follow all study procedures; especially the randomized antiplatelet treatment regimen\n* Participant is willing to sign the study informed consent form\n\nExclusion Criteria:\n\n* Indications to dual antiplatelet therapy other than atrial fibrillation and\u002For left atrial appendage occlusion at the time of enrollment or predicted appearance of such indications within the duration of the trial (e.g. planned coronary revascularization)\n* Indications to anticoagulation at the time of enrollment and\u002For predicted appearance of such indications within the duration of the trial (e.g. pulmonary embolism)\n* Known allergy to clopidogrel and\u002For acetylsalicylic acid precluding its administration as specified by the protocol\n* Any known inborn or acquired coagulation disorders\n* Peridevice leak \\>5mm on imaging study preceding enrollment\n* Left atrial thrombus on an imaging study performed after successful left atrial appendage closure but before enrollment\n* Life expectancy of fewer than 18 months\n* Participation in other clinical studies with experimental therapies at the time of enrollment and preceding 3 months\n* Chronic kidney disease stage IV and V\n* Women who are pregnant or breastfeeding; women of childbearing potential who do not consent to apply at least two methods of contraception. This criterion does not apply to women 2 years post menopause (with negative pregnancy test 24 hours prior to randomization if \\\u003C55 years old) or after surgical sterilization","ALL","18 Years",{"count":97,"type":98},200,"ESTIMATED","INTERVENTIONAL",[101],"PHASE4","SAFE-LAAC Trial has been designed to gather data on the most optimal strategy of antiplatelet therapy after transcatheter left atrial appendage occlusion with Amplatzer or WATCHMAN device",[104],"Atrial Fibrillation",[106],"atrial fibrillation, stroke, bleeding, left atrial appendage","2023-07-10",{"date":109,"type":110},"2023-07-11","ACTUAL",{"date":112,"type":110},"2018-01-23",{"date":114,"type":98},"2027-06-23",{"name":5,"class":6},1]