International Registry of Thrombotic APS Patients Treated With Direct Oral Anticoagulants
OBSTINATE
OBServaToire INternational Des Patients AnTiphospholipidEs traités Par Anticoagulants Oraux Directs
Sponsor study identifier
observational
500
1 country
1
Study Start
October 21, 2020
Actual (reported)Primary Completion
April 21, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
April 21, 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
This registry, currently being established will ensure consistency of data collection and provide safety information in non high-risk APS patients currently on DOACs.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 21, 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 6, 2020
Actual (reported)February 10, 2020
Actual (reported)October 21, 2020
Actual (reported)April 21, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
April 21, 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Rate of Recurrent Thrombosis
Rate of Recurrent Thrombosis either arterial, venous or microvascular confirmed by a relevant exam
6 months
Rate of Bleeding
6 months
Rate of Non-Criteria Manifestations
6 months
Adherence to treatment
6 months
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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Thrombotic APS patients according to revised Sapporo-Sydney criteria
Stéphane Zuily
Nancy, 54500, France
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.
First Submitted
February 6, 2020
First Posted
February 10, 2020
Study Start
October 21, 2020
Actual (reported)Primary Completion
April 21, 2030
EstimatedRivaroxaban Versus Standard of Care for Patients With Excessive Atrial Ectopy or Short Atrial Runs and High Embolism Risk
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
April 21, 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
May 8, 2026
Record last verified: 2026-05
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Source: ClinicalTrials.gov.
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