International Registry of Thrombotic APS Patients Treated With Direct Oral Anticoagulants

Stéphane Zuily500 enrolled

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.

Study Type

OBSERVATIONAL

Enrollment

500

Conditions

Antiphospholipid Syndrome Thrombosis Anticoagulants Causing Adverse Effects in Therapeutic Use

Interventions

RivaroxabanDRUG

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

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

Stéphane Zuily

Nancy, France

RECRUITING

Outcomes

Primary Outcomes

Rate of Recurrent Thrombosis

Rate of Recurrent Thrombosis either arterial, venous or microvascular confirmed by a relevant exam

Time frame: 6 months

Secondary Outcomes

Rate of Bleeding

Rate of Bleeding either severe or major or clinically relevant non-major bleeding according to ISTH classification

Time frame: 6 months

Rate of Non-Criteria Manifestations

Rate of Non-Criteria Manifestations according to Sydney criteria

Time frame: 6 months

Adherence to treatment

Rate of patients who have a good adherence to oral anticoagulants assessed by the Girerd questionnaire

Time frame: 6 months

Central Contacts

Virginie Dufrost, MD, MSc

CONTACT

+33383157828 v.dufrost@chru-nancy.Fr

Data from ClinicalTrials.gov

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