International Registry of Thrombotic APS Patients Treated With Direct Oral Anticoagulants
NCT ID: NCT04262492
Last Updated: 2024-02-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
500 participants
OBSERVATIONAL
2020-10-21
2030-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Rivaroxaban
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age ≥ 18 yo
* Classification of definite APS according to revised Sapporo-Sydney criteria
* Direct oral anticoagulant treatment prescribed during at least 6 months or with the possibility of follow-up of at least 6 months
Exclusion Criteria
* No data regarding the recurrent thrombosis
* Pregnant woman
* Age \< 18 yo
ALL
No
Sponsors
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International Society on Thrombosis and Haemostasis
UNKNOWN
Stéphane Zuily
OTHER
Responsible Party
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Stéphane Zuily
Professor
Locations
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Stéphane Zuily
Nancy, , France
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
Related Links
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ISTH SSC LA/aPL project
OBSTINATE webpage
Other Identifiers
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2019-A01415-52
Identifier Type: -
Identifier Source: org_study_id
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