Ignite Creation Date:
2025-12-24 @ 3:16 PM
Ignite Modification Date:
2025-12-27 @ 1:48 AM
Study NCT ID:
NCT04262492
Status:
RECRUITING
Last Update Posted:
2024-02-09
First Post:
2020-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
International Registry of Thrombotic APS Patients Treated With Direct Oral Anticoagulants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016736', 'term': 'Antiphospholipid Syndrome'}, {'id': 'D013927', 'term': 'Thrombosis'}], 'ancestors': [{'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069552', 'term': 'Rivaroxaban'}, {'id': 'D000069604', 'term': 'Dabigatran'}, {'id': 'C522181', 'term': 'apixaban'}, {'id': 'C552171', 'term': 'edoxaban'}], 'ancestors': [{'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009025', 'term': 'Morpholines'}, {'id': 'D010078', 'term': 'Oxazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-10-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2030-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-07', 'studyFirstSubmitDate': '2020-02-06', 'studyFirstSubmitQcDate': '2020-02-07', 'lastUpdatePostDateStruct': {'date': '2024-02-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of Recurrent Thrombosis', 'timeFrame': '6 months', 'description': 'Rate of Recurrent Thrombosis either arterial, venous or microvascular confirmed by a relevant exam'}], 'secondaryOutcomes': [{'measure': 'Rate of Bleeding', 'timeFrame': '6 months', 'description': 'Rate of Bleeding either severe or major or clinically relevant non-major bleeding according to ISTH classification'}, {'measure': 'Rate of Non-Criteria Manifestations', 'timeFrame': '6 months', 'description': 'Rate of Non-Criteria Manifestations according to Sydney criteria'}, {'measure': 'Adherence to treatment', 'timeFrame': '6 months', 'description': 'Rate of patients who have a good adherence to oral anticoagulants assessed by the Girerd questionnaire'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['antiphospholipid syndrome', 'direct oral anticoagulants'], 'conditions': ['Antiphospholipid Syndrome', 'Thrombosis', 'Anticoagulants Causing Adverse Effects in Therapeutic Use']}, 'referencesModule': {'references': [{'pmid': '30103045', 'type': 'BACKGROUND', 'citation': 'Dufrost V, Risse J, Reshetnyak T, Satybaldyeva M, Du Y, Yan XX, Salta S, Gerotziafas G, Jing ZC, Elalamy I, Wahl D, Zuily S. Increased risk of thrombosis in antiphospholipid syndrome patients treated with direct oral anticoagulants. Results from an international patient-level data meta-analysis. Autoimmun Rev. 2018 Oct;17(10):1011-1021. doi: 10.1016/j.autrev.2018.04.009. Epub 2018 Aug 11.'}, {'pmid': '28741234', 'type': 'BACKGROUND', 'citation': 'Dufrost V, Risse J, Wahl D, Zuily S. Direct Oral Anticoagulants Use in Antiphospholipid Syndrome: Are These Drugs an Effective and Safe Alternative to Warfarin? A Systematic Review of the Literature: Response to Comment. Curr Rheumatol Rep. 2017 Aug;19(8):52. doi: 10.1007/s11926-017-0676-2. No abstract available.'}], 'seeAlsoLinks': [{'url': 'https://cdn.ymaws.com/www.isth.org/resource/resmgr/subcommittees/registry_on_doacs_in_aps_pro.pdf', 'label': 'ISTH SSC LA/aPL project'}, {'url': 'https://apsnancy.com/Research-Projects.php', 'label': 'OBSTINATE webpage'}]}, 'descriptionModule': {'briefSummary': 'This registry, currently being established will ensure consistency of data collection and provide safety information in non high-risk APS patients currently on DOACs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Thrombotic APS patients according to revised Sapporo-Sydney criteria', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient receiving a comprehensive information about the study, and not opposed to participate\n* Age ≥ 18 yo\n* Classification of definite APS according to revised Sapporo-Sydney criteria\n* Direct oral anticoagulant treatment prescribed during at least 6 months or with the possibility of follow-up of at least 6 months\n\nExclusion Criteria:\n\n* Incomplete revised Sapporo-Sydney criteria\n* No data regarding the recurrent thrombosis\n* Pregnant woman\n* Age \\< 18 yo'}, 'identificationModule': {'nctId': 'NCT04262492', 'acronym': 'OBSTINATE', 'briefTitle': 'International Registry of Thrombotic APS Patients Treated With Direct Oral Anticoagulants', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'OBServaToire INternational Des Patients AnTiphospholipidEs traités Par Anticoagulants Oraux Directs', 'orgStudyIdInfo': {'id': '2019-A01415-52'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Rivaroxaban', 'type': 'DRUG', 'otherNames': ['Dabigatran', 'Apixaban', 'Edoxaban'], 'description': 'Rivaroxaban 10 mg or 15 mg or 20 mg OD Dabigatran 110 mg or 150 mg BID Apixaban 2.5 mg or 5 mg or 10 mg BID'}]}, 'contactsLocationsModule': {'locations': [{'zip': '54500', 'city': 'Nancy', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Stéphane Zuily, MD, PhD', 'role': 'CONTACT', 'email': 's.zuily@chru-nancy.fr', 'phone': '+33383157354'}, {'name': 'Virginie Dufrost, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Denis Wahl, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Stéphane Zuily, MD, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Stéphane Zuily', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}], 'centralContacts': [{'name': 'Virginie Dufrost, MD, MSc', 'role': 'CONTACT', 'email': 'v.dufrost@chru-nancy.Fr', 'phone': '+33383157828'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stéphane Zuily', 'class': 'OTHER'}, 'collaborators': [{'name': 'International Society on Thrombosis and Haemostasis', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Stéphane Zuily', 'investigatorAffiliation': 'Central Hospital, Nancy, France'}}}}