International Registry of Thrombotic APS Patients Treated With Direct Oral Anticoagulants

Thrombosis Clinical Trial

— OBSTINATE  

Official title:

OBServaToire INternational Des Patients AnTiphospholipidEs traités Par Anticoagulants Oraux Directs

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04262492
• Other study ID #: 2019-A01415-52
• Status: Recruiting
• Start date: October 21, 2020
• Est. completion date: April 2030

Study information

• Verified date: February 2024
• Source: Central Hospital, Nancy, France
• Contact: Virginie Dufrost, MD, MSc
• Phone: +33383157828
• Email: v.dufrost[@]chru-nancy.Fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This registry, currently being established will ensure consistency of data collection and provide safety information in non high-risk APS patients currently on DOACs.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: April 2030
• Est. primary completion date: April 2030
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Anticoagulants Causing Adverse Effects in Therapeutic Use
• Antiphospholipid Syndrome
• Thrombosis

Intervention

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

Locations

Country	Name	City	State
France	Stéphane Zuily	Nancy

Sponsors (2)

Lead Sponsor	Collaborator
Stéphane Zuily	International Society on Thrombosis and Haemostasis

Country where clinical trial is conducted

France, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Recurrent Thrombosis	Rate of Recurrent Thrombosis either arterial, venous or microvascular confirmed by a relevant exam	6 months
Secondary	Rate of Bleeding	Rate of Bleeding either severe or major or clinically relevant non-major bleeding according to ISTH classification	6 months
Secondary	Rate of Non-Criteria Manifestations	Rate of Non-Criteria Manifestations according to Sydney criteria	6 months
Secondary	Adherence to treatment	Rate of patients who have a good adherence to oral anticoagulants assessed by the Girerd questionnaire	6 months

External Links

•   ISTH SSC LA/aPL project
•   OBSTINATE webpage