[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"thrombotic-and-bleeding-events\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:thrombotic-and-bleeding-events":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"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":4,"briefSummary":23,"conditions":24,"keywords":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"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":20,"type":21},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.",[25,26,27],"Antiphospholipid Syndrome (APS)","Cohort Study","Thrombotic and Bleeding Events",[29,30,31,32,33],"Antiphospholipid Syndrome","VKA treatment","DOAC Treatment","biological analysis","Thrombotic and bleeding events","NOT_YET_RECRUITING","2025-06-11",{"date":37,"type":38},"2025-06-13","ACTUAL",{"date":40,"type":21},"2025-09-15",{"date":42,"type":21},"2031-09-15",{"name":44,"class":45},"Central Hospital, Nancy, France","OTHER",13,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":55,"targetDuration":57,"studyType":22,"phases":4,"briefSummary":58,"conditions":59,"keywords":62,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":76},"100587499","observatoire-international-des-patients-antiphospholipides-traits-par-anticoagulants-oraux-directs-100587499","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",{"count":56,"type":21},500,"5 Years","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.",[25,60,27,61],"Direct Oral Anticoagulants (DOACs)","Safety",[63,64,65,66,67],"safety of DOACs",""non-high risk" APS patients","Observatory","Phase IV","International","2025-04-16",{"date":70,"type":38},"2025-04-20",{"date":72,"type":21},"2025-07-01",{"date":74,"type":21},"2035-07-01",{"name":44,"class":45},1]