[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100587499":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":10,"locations":24,"responsibleParty":44,"collaborators":10,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":49,"sex":55,"minAge":56,"maxAge":10,"enrollmentInfo":57,"targetDuration":60,"studyType":61,"phases":10,"briefSummary":62,"conditions":63,"keywords":68,"overallStatus":74,"whyStopped":10,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"Central Hospital, Nancy, France","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Population of \"non-high risk\" thrombotic APS patients treated with DOAC",null,"Non-high-risk\" APS is defined by the absence of a history of arterial or microcirculatory thrombosis, the absence of valvulopathy related to APS, and a biological profile with only one or two positive antiphospholipid tests",[13],"Other: \"non-high risk\" thrombotic APS patients treated with DOAC",[15],{"type":6,"name":16,"description":17,"armGroupLabels":18,"otherNames":10},"\"non-high risk\" thrombotic APS patients treated with DOAC","There is no specific intervention in this study. Routine care data will be collected from patients with a 'non-high-risk' APS profile who are currently being treated with DOACs or have been in the past.",[9],[20],{"name":21,"affiliation":22,"role":23},"Virginie DUFROST, MD","CHRU - Nancy","PRINCIPAL_INVESTIGATOR",[25],{"facility":26,"status":10,"city":27,"state":10,"zip":28,"country":29,"countryCode":30,"cosmosGeoPoint":31,"geoPoint":36,"contacts":37},"Vall d´Hebron University Hospital","Barcelona","08035","Spain","ES",{"type":32,"coordinates":33},"Point",[34,35],2.15899,41.38879,{"lat":35,"lon":34},[38,42],{"name":39,"role":40,"phone":10,"phoneExt":10,"email":41},"Jose Pardos-Gea, MD,PhD","CONTACT","jpardos@vhebron.net",{"name":43,"role":23,"phone":10,"phoneExt":10,"email":10},"Jose Pardos-Gea, MD, PhD",{"type":23,"investigatorFullName":45,"investigatorTitle":46,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Virginie Dufrost","Principal Investigator","100587499","observatoire-international-des-patients-antiphospholipides-traits-par-anticoagulants-oraux-directs-100587499",false,"NCT06929182","OBServaToIre interNational Des Patients AnTiphospholipidEs traités Par Anticoagulants Oraux Directs","OBServaToIre National Des Patients AnTiphospholipidEs traités Par Anticoagulants Oraux Directs","OBSTINATE 2","Inclusion Criteria:\n\n* Person having received complete information on the organization of the research and not having opposed the use of this data\n* Male or female aged 18 and over;\n* Carrier of a thrombotic APS according to the Sydney classification criteria, regardless of the length of time in the disease\n* Having received a direct oral anticoagulant (DOAC) treatment which is currently discontinued.\n* Or currently treated with DOAC\n\nExclusion Criteria:\n\n* Incomplete Sydney classification criteria\n* Presence of a triple antiphospholipid positivity\n* History of arterial thrombosis\n* Persons referred to in Articles L. 1121-5, L. 1121-7 and L1121-8 of the French Public Health Code:\n\n  * Pregnant, parturient or nursing mother\n  * Minor person (not emancipated)\n  * Adult person subject to a legal protection measure (guardianship, curatorship, safeguard of justice)\n  * Person of full age unable to express consent\n* Persons deprived of their liberty by a judicial or administrative decision, persons undergoing psychiatric treatment under Articles L. 3212-1 and L. 3213-1 of the French Public Health Code.\n* Signature of the research participation opposition form","ALL","18 Years",{"count":58,"type":59},500,"ESTIMATED","5 Years","OBSERVATIONAL","This registry will make it possible to collect large-scale data on SAPL patients, particularly those treated with DOACs, in order to better assess the frequency of thrombotic and hemorrhagic events in this population of \"non-high-risk\" thrombotic SAPL patients treated with DOACs. The results will help refine treatment recommendations and could form the basis of future clinical trials.\n\nIn this study, there will be no modification of the usual care and no additional follow-up. Follow-up will be carried out during the patient's usual visits in the context of his or her pathology, the frequency of which will be left to the discretion of the usual physician. No additional consultations\u002Fhospitalizations\u002Fexaminations will be carried out as part of the study. Data normally recorded in the medical record will be collected over a 5-year period, in line with standard patient follow-up.",[64,65,66,67],"Antiphospholipid Syndrome (APS)","Direct Oral Anticoagulants (DOACs)","Thrombotic and Bleeding Events","Safety",[69,70,71,72,73],"safety of DOACs",""non-high risk" APS patients","Observatory","Phase IV","International","NOT_YET_RECRUITING","2025-04-16",{"date":77,"type":78},"2025-04-20","ACTUAL",{"date":80,"type":59},"2025-07-01",{"date":82,"type":59},"2035-07-01",{"name":5,"class":6},1]