Recruiting NCT04262492
International Registry of Thrombotic APS Patients Treated With Direct Oral Anticoagulants
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Rivaroxaban.
- Who it may be relevant to
- Registry conditions: Antiphospholipid Syndrome, Thrombosis, Anticoagulants Causing Adverse Effects in Therapeutic Use. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
OBServaToire INternational Des Patients AnTiphospholipidEs traités Par Anticoagulants Oraux Directs
Overview
This registry, currently being established will ensure consistency of data collection and provide safety information in non high-risk APS patients currently on DOACs.
Interventions
- Drug 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
Primary outcome measures
- Rate of Recurrent Thrombosis [Time frame: 6 months]
Secondary outcome measures (3)
- Rate of Bleeding [Time frame: 6 months]
- Rate of Non-Criteria Manifestations [Time frame: 6 months]
- Adherence to treatment [Time frame: 6 months]
Eligibility criteria
Inclusion criteria
- Patient receiving a comprehensive information about the study, and not opposed to participate
- 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
- Incomplete revised Sapporo-Sydney criteria
- No data regarding the recurrent thrombosis
- Pregnant woman
- Age < 18 yo
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Stéphane Zuily — Nancy
Publications
- 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 30103045
- 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. PMID 28741234
Identifiers
NCT: NCT04262492 · 2019-A01415-52