International Registry of Thrombotic APS Patients Treated With Direct Oral Anticoagulants

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorStéphane Zuily

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Incomplete revised Sapporo-Sydney criteria

No data regarding the recurrent thrombosis

Pregnant woman

Age < 18 yo

Trial population

Thrombotic APS patients according to revised Sapporo-Sydney criteria

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Rivaroxaban

    Drug

    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

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Rate of Recurrent Thrombosis

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

Time frame
6 months

Secondary outcomes

1

Rate of Bleeding

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

Time frame
6 months
2

Rate of Non-Criteria Manifestations

Rate of Non-Criteria Manifestations according to Sydney criteria

Time frame
6 months
3

Adherence to treatment

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

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Stéphane Zuily

Lead sponsor

Central Hospital, Nancy, France

Sponsor institution

International Society on Thrombosis and Haemostasis

Collaborator