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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04262492
Other study ID # 2019-A01415-52
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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

Study Design


Related Conditions & MeSH terms


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
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