[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100584057":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":39,"centralContacts":10,"locations":44,"responsibleParty":260,"collaborators":10,"id":263,"slug":264,"hasResults":265,"nctId":266,"briefTitle":267,"officialTitle":268,"acronym":269,"eligibilityCriteria":270,"healthyVolunteers":265,"sex":271,"minAge":272,"maxAge":10,"enrollmentInfo":273,"targetDuration":10,"studyType":276,"phases":10,"briefSummary":277,"conditions":278,"keywords":282,"overallStatus":288,"whyStopped":10,"lastUpdateSubmitDate":289,"lastUpdatePostDateStruct":290,"startDateStruct":293,"completionDateStruct":295,"leadSponsor":297,"locationsCount":298},{"fullName":5,"class":6},"Central Hospital, Nancy, France","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Patient with VKA treatment",null,"Population of \"non-high-risk\" thrombotic APS patients treated with VKAs, regardless of how long they have been on therapy. \"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.",[13,14,15],"Biological: Additional blood collection during routine blood sampling at the inclusion (33.9 ml) and at the thrombotic recurrence (between 3.5 and 5 ml)","Behavioral: Completion of a questionnaire on compliance with anticoagulant treatment","Behavioral: Completion of a questionnaire on satisfaction with treatment anticoagulant",{"label":17,"type":10,"description":18,"interventionNames":19},"Patient with DOAC treatment","Population of \"non-high-risk\" thrombotic APS patients treated with oral AntiXa, regardless of how long they have been treated. 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.",[13,14,15],[21,26,33],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":10},"BIOLOGICAL","Additional blood collection during routine blood sampling at the inclusion (33.9 ml) and at the thrombotic recurrence (between 3.5 and 5 ml)","At inclusion, the blood sample is used to perform thrombin generation tests (activated protein C resistance profile and ratio), classical and innovative aPL assays centrally to limit the fluctuation inherent in the tests used and enable comparison between patients, immunothrombosis markers: circulating neutrophil extracellular traps (NETs) assay, sTREM-1 assay\n\nIn the event of recurrence, blood sampling can be used to confirm compliance with treatment by measuring the anti Xa activity of the drug or INR",[17,9],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"BEHAVIORAL","Completion of a questionnaire on compliance with anticoagulant treatment","The Girerd questionnaire (6 questions) will be proposed to patients in order to estimate the degree of compliance with AODs and VKAs at inclusion and at each follow-up visit for the duration of their participation in the study.",[17,9],[32],"GIRERD questionnaire",{"type":27,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"Completion of a questionnaire on satisfaction with treatment anticoagulant","The ACTS questionnaire (15 questions) will be proposed to them in order to estimate their satisfaction with their anticoagulant treatment (AOD or AVK) at inclusion and at each follow-up visit for the duration of their participation in the study.",[17,9],[38],"Anti-Clot Treatment Scale - ACTS",[40],{"name":41,"affiliation":42,"role":43},"Virginie DUFROST, MD","CHRU - Nancy","PRINCIPAL_INVESTIGATOR",[45,69,88,104,119,136,151,166,181,196,213,228,243],{"facility":5,"status":10,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Vandœuvre-lès-Nancy","Grand Est","54500","France","FR",{"type":52,"coordinates":53},"Point",[54,55],6.17114,48.66115,{"lat":55,"lon":54},[58,63,66,67],{"name":41,"role":59,"phone":60,"phoneExt":61,"email":62},"CONTACT","0383157828","+33","v.dufrost@chru-nancy.fr",{"name":64,"role":59,"phone":10,"phoneExt":10,"email":65},"Denis WAHL, MD, PhD","d.wahl@chru-nancy.fr",{"name":41,"role":43,"phone":10,"phoneExt":10,"email":10},{"name":68,"role":43,"phone":10,"phoneExt":10,"email":10},"Thomas MOULINET, MD, PhD",{"facility":70,"status":10,"city":71,"state":10,"zip":72,"country":49,"countryCode":50,"cosmosGeoPoint":73,"geoPoint":77,"contacts":78},"CHU d'Amiens","Amiens","80054",{"type":52,"coordinates":74},[75,76],2.3,49.9,{"lat":76,"lon":75},[79,83,85],{"name":80,"role":59,"phone":81,"phoneExt":10,"email":82},"Simon Soudet","000000000","Soudet.Simon@chu-amiens.fr",{"name":84,"role":43,"phone":10,"phoneExt":10,"email":10},"Simon SOUDET",{"name":86,"role":87,"phone":10,"phoneExt":10,"email":10},"Valery SALLE","SUB_INVESTIGATOR",{"facility":89,"status":10,"city":90,"state":10,"zip":91,"country":49,"countryCode":50,"cosmosGeoPoint":92,"geoPoint":96,"contacts":97},"CHU de Besançon","Besançon","25030",{"type":52,"coordinates":93},[94,95],6.01815,47.24878,{"lat":95,"lon":94},[98,102],{"name":99,"role":59,"phone":100,"phoneExt":10,"email":101},"Nadine Magy-Bertrand","00000000","nadine.magy@univ-fcomte.fr",{"name":103,"role":43,"phone":10,"phoneExt":10,"email":10},"Nadine MAGY BERTRAND",{"facility":105,"status":10,"city":106,"state":10,"zip":107,"country":49,"countryCode":50,"cosmosGeoPoint":108,"geoPoint":112,"contacts":113},"CHU de Brest","Brest","29200",{"type":52,"coordinates":109},[110,111],-4.48628,48.39029,{"lat":111,"lon":110},[114,117],{"name":115,"role":59,"phone":100,"phoneExt":10,"email":116},"Francis Couturaud","francis.couturaud@chu-brest.fr",{"name":118,"role":43,"phone":10,"phoneExt":10,"email":10},"Francis COUTURAUD",{"facility":120,"status":10,"city":121,"state":10,"zip":122,"country":49,"countryCode":50,"cosmosGeoPoint":123,"geoPoint":127,"contacts":128},"CHU de Dijon","Dijon","21079",{"type":52,"coordinates":124},[125,126],5.01391,47.31344,{"lat":126,"lon":125},[129,132,134],{"name":130,"role":59,"phone":100,"phoneExt":61,"email":131},"Hélène Greigert, MD","helene.greigert@chu-dijon.fr",{"name":133,"role":43,"phone":10,"phoneExt":10,"email":10},"Hélène GREIGERT",{"name":135,"role":87,"phone":10,"phoneExt":10,"email":10},"Najib EL HSSAINI",{"facility":137,"status":10,"city":138,"state":10,"zip":139,"country":49,"countryCode":50,"cosmosGeoPoint":140,"geoPoint":144,"contacts":145},"CHU de Lyon","Lyon","69003",{"type":52,"coordinates":141},[142,143],4.84789,45.74906,{"lat":143,"lon":142},[146,149],{"name":147,"role":59,"phone":100,"phoneExt":10,"email":148},"Thomas Barba","thomas.barba@chu-lyon.fr",{"name":150,"role":43,"phone":10,"phoneExt":10,"email":10},"Thomas BARBA",{"facility":152,"status":10,"city":153,"state":10,"zip":154,"country":49,"countryCode":50,"cosmosGeoPoint":155,"geoPoint":159,"contacts":160},"Hôpital Robert Schuman, UNEOS","Metz","57000",{"type":52,"coordinates":156},[157,158],6.17269,49.11911,{"lat":158,"lon":157},[161,164],{"name":162,"role":59,"phone":100,"phoneExt":61,"email":163},"Julien Campagne","julien.campagne@uneos.fr",{"name":165,"role":43,"phone":10,"phoneExt":10,"email":10},"Julien CAMPAGNE",{"facility":167,"status":10,"city":168,"state":10,"zip":169,"country":49,"countryCode":50,"cosmosGeoPoint":170,"geoPoint":174,"contacts":175},"CH de Mulhouse","Mulhouse","68100",{"type":52,"coordinates":171},[172,173],7.32866,47.75205,{"lat":173,"lon":172},[176,179],{"name":177,"role":59,"phone":100,"phoneExt":10,"email":178},"Amer Hamade","HAMADEA@ghrmsa.fr",{"name":180,"role":43,"phone":10,"phoneExt":10,"email":10},"Amer HAMADE",{"facility":182,"status":10,"city":183,"state":10,"zip":184,"country":49,"countryCode":50,"cosmosGeoPoint":185,"geoPoint":189,"contacts":190},"CHU de Nantes","Nantes","44800",{"type":52,"coordinates":186},[187,188],-1.55336,47.21725,{"lat":188,"lon":187},[191,194],{"name":192,"role":59,"phone":100,"phoneExt":10,"email":193},"Olivier Espitia","Olivier.ESPITIA@chu-nantes.fr",{"name":195,"role":43,"phone":10,"phoneExt":10,"email":10},"Olivier ESPITIA",{"facility":197,"status":10,"city":198,"state":10,"zip":199,"country":49,"countryCode":50,"cosmosGeoPoint":200,"geoPoint":204,"contacts":205},"Hôpital Lariboisière - APHP","Paris","75010",{"type":52,"coordinates":201},[202,203],2.3488,48.85341,{"lat":203,"lon":202},[206,209,211],{"name":207,"role":59,"phone":100,"phoneExt":10,"email":208},"Maxime Delrue","maxime.delrue@aphp.fr",{"name":210,"role":43,"phone":10,"phoneExt":10,"email":10},"Maxime DELRUE",{"name":212,"role":87,"phone":10,"phoneExt":10,"email":10},"Damien SENE",{"facility":214,"status":10,"city":215,"state":10,"zip":216,"country":49,"countryCode":50,"cosmosGeoPoint":217,"geoPoint":221,"contacts":222},"CHU de Reims","Reims","51100",{"type":52,"coordinates":218},[219,220],4.02853,49.26526,{"lat":220,"lon":219},[223,226],{"name":224,"role":59,"phone":81,"phoneExt":10,"email":225},"Amélie Servettaz","aservettaz@chu-reims.fr",{"name":227,"role":43,"phone":10,"phoneExt":10,"email":10},"Amélie SERVETTAZ",{"facility":229,"status":10,"city":230,"state":10,"zip":231,"country":49,"countryCode":50,"cosmosGeoPoint":232,"geoPoint":236,"contacts":237},"CHU de Saint Etienne","Saint-Priest-en-Jarez","42270",{"type":52,"coordinates":233},[234,235],4.37678,45.4739,{"lat":235,"lon":234},[238,241],{"name":239,"role":59,"phone":100,"phoneExt":10,"email":240},"Géraldine Poenou","Geraldine.Poenou@chu-st-etienne.fr",{"name":242,"role":43,"phone":10,"phoneExt":10,"email":10},"Géraldine POENOU",{"facility":244,"status":10,"city":245,"state":10,"zip":246,"country":49,"countryCode":50,"cosmosGeoPoint":247,"geoPoint":251,"contacts":252},"CHU de Strasbourg - Hôpital civil","Strasbourg","67091",{"type":52,"coordinates":248},[249,250],7.74553,48.58392,{"lat":250,"lon":249},[253,256,258],{"name":254,"role":59,"phone":100,"phoneExt":10,"email":255},"Dominique Stephan","Dominique.Stephan@chru-strasbourg.fr",{"name":257,"role":43,"phone":10,"phoneExt":10,"email":10},"Dominique STEPHAN",{"name":259,"role":43,"phone":10,"phoneExt":10,"email":10},"Anne Sophie KORGANOW",{"type":43,"investigatorFullName":261,"investigatorTitle":262,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Virginie Dufrost","Principal Investigator","100584057","doac-versus-vka-in-patients-with-non-high-risk-aps--prospective-cohort-study-100584057",false,"NCT06884384","DOAC Versus VKA in Patients With Non-high-risk APS : Prospective Cohort Study","Direct Oral Anticoagulants Versus Warfarin in Patients With Non-high-risk Antiphospholipid Syndrome : Prospective Cohort Study","DOWAPS","Inclusion Criteria:\n\n* Persons who have received full information about the organization of the research and have given their oral consent to participate.\n* Male or female 18 years of age or older;\n* Carrier of venous thrombotic SAPL:\n\n  * Not favoured by a major or ≥ 2 minor favouring factors, if the patient doesn't present with obstetrical SAPL in accordance with the ACR\u002FEULAR 2023 clinical classification criteria.\n  * Or favored by ≥ 2 minors, if the patient has obstetrical SAPL: severe preeclampsia \\\u003C 34 weeks or placental insufficiency\n  * Regardless of how long the disease has been present\n  * With persistent positivity of at least one biological criterion:\n\n    * Positivity of circulating lupus anticoagulant or IgG anticardiolipid or IgG anti-beta-2GPI\n    * And persistence of the same positive test ≥ 12 weeks apart\n    * And With maximum delay of positivity of the 1st antiphospholipid test of 3 years after the thrombotic event\n* Current anticoagulant treatment, regardless of date of introduction\n\n  * rivaroxaban or apixaban\n  * or antivitamin K\n* Patient affiliated to a social security system\n\nExclusion Criteria:\n\n* Venous thrombotic event motivating current anticoagulant treatment favoured by a major favouring factor:\n\n  * Active cancer\n  * Hospitalization with bed rest for at least 3 days in the 3 months preceding the event\n  * Major trauma with fractures or spinal cord injury in the month preceding the event\n  * Surgery with general\u002Fspinal\u002Fepidural anesthesia for \\> 30 minutes in the 3 months preceding the event.\n* In the absence of a history of pre-eclampsia or placental insufficiency: venous thrombotic event motivating current anticoagulant treatment favoured by 2 or more minor favouring factors:\n\n  * Systemic autoimmune disease or active inflammatory bowel disease\n  * Acute\u002Fsevere infection\n  * Central venous catheter in the same vascular bed\n  * Hormone replacement therapy, estrogenic oral contraceptives, or hormone-stimulating therapy in progress\n  * Long-distance travel (≥ 8 hours)\n  * Obesity (BMI ≥ 30 kg\u002Fm²)\n  * Pregnancy or post-partum (6 weeks after delivery)\n  * Prolonged immobilization\n  * Surgery with general\u002Fspinal\u002Fepidural anesthesia for \\\u003C 30 minutes in the 3 months preceding the event\n* Known triple antiphospholipid positivity\n* Isolated IgM antiphospholipid positivity\n* History of known arterial thrombosis\n* History of known microcirculatory thrombosis\n* Known SAPL-related cardiac valvular disease\n* Persons referred to in articles L. 1121-5, L. 1121-7 and L1121-8 of the Public Health Code\n* Persons deprived of their liberty by judicial or administrative decision, persons under psychiatric care under articles L. 3212-1 and L. 3213-1.\n* Glomerular filtration rate \\\u003C 30ml\u002Fmin.\n* Weight \\\u003C 50kg\n* History of thrombotic recurrence under well-administered anticoagulant therapy.","ALL","18 Years",{"count":274,"type":275},310,"ESTIMATED","OBSERVATIONAL","Antiphospholipid syndrome (APS) is a thrombotic disease requiring prolonged anticoagulation. Direct oral anticoagulants (DOACs) are indicated as 1st-line therapy in venous thrombosis, compared with VKAs, due to their easier handling and lower bleeding risk for equivalent efficacy. In APS, VKAs are still the reference treatment. However, DOACs are generally introduced in the acute phase of venous, before the diagnosis of APS. VKA have the disadvantage of numerous food and drug interactions, and therefore require close monitoring of INR, at least once a month. Because they are easier to use than VKAs, and the risk of bleeding is lower, patients are often reluctant to switch from DOACs to VKA. Studies have shown that APS patients with high thrombotic risk (positivity of all three antiphospholipid tests, history of arterial or small vessels thrombosis or cardiac valve damage) have an increased thrombotic risk during DOACs vs. VKA treatment. Since 2020, the ISTH guidelines have suggested avoiding DOACs in high-risk APS, but suggest continuing theim in other patients if they were introduced for venous thrombosis and if follow-up on DOACs is reassuring. In the case of high-risk APS patients, the relay is therefore systematic. For non-high-risk patients (the majority), there are no data to justify systematic switch. Given the quality-of-life advantages of DOACs over VKAs, patients are not always in favor of changing their anticoagulant therapy, especially if they have been on it for many years with good tolerability. For these reasons, a number of patients with non-high-risk APS remain on DOACs. Nevertheless, the limited data available on the efficacy of DOACs in non-high-risk patients are of low level of evidence and contradictory. In 2020, a literature review of non-high-risk SAPL patients treated with DOACs reported that 8.6% of them experienced thrombotic recurrence within 12 months, with no possible comparison with VKAs. A recent retrospective study with 96 patients reported that 15.4% of patients treated with DOACs had a recurrence, compared to 5.3% on VKAs. However, this difference was not statistically significant (p=0.15) due to a clear lack of power. The objective is to determine the frequency of thrombotic recurrences and to compare it according to the type of oral treatment, anti-Xa versus VKA, in non-high-risk APS, through a cohort study with prospective follow-up. The patient's usual antithrombotic treatment, DOAC and VKA, will be continued unchanged.",[279,280,281],"Antiphospholipid Syndrome (APS)","Cohort Study","Thrombotic and Bleeding Events",[283,284,285,286,287],"Antiphospholipid Syndrome","VKA treatment","DOAC Treatment","biological analysis","Thrombotic and bleeding events","NOT_YET_RECRUITING","2025-06-11",{"date":291,"type":292},"2025-06-13","ACTUAL",{"date":294,"type":275},"2025-09-15",{"date":296,"type":275},"2031-09-15",{"name":5,"class":6},13]