International Registry of Thrombotic APS Patients Treated With Direct Oral Anticoagulants

Recruiting

• Conditions: Antiphospholipid Syndrome; Thrombosis; Anticoagulants Causing Adverse Effects in Therapeutic Use

• Registration Number: NCT04262492
• Lead Sponsor: Stéphane Zuily

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-06
• Study First Submitted QC: 2020-02-07
• Study First Posted: 2020-02-10
• Study Start: 2020-10-21
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-07
• Last Update Posted: 2024-02-09
• Primary Completion: 2030-04
• Study Completion: 2030-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of Recurrent Thrombosis	6 months	Rate of Recurrent Thrombosis either arterial, venous or microvascular confirmed by a relevant exam

Secondary Outcome Measures

Name	Time	Method
Rate of Bleeding	6 months	Rate of Bleeding either severe or major or clinically relevant non-major bleeding according to ISTH classification
Adherence to treatment	6 months	Rate of patients who have a good adherence to oral anticoagulants assessed by the Girerd questionnaire
Rate of Non-Criteria Manifestations	6 months	Rate of Non-Criteria Manifestations according to Sydney criteria

Trial Locations

Locations (1)

Stéphane Zuily; 🇫🇷 Nancy, France