OBServaToIre interNational Des Patients AnTiphospholipidEs traités Par Anticoagulants Oraux Directs

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentral Hospital, Nancy, France

About this trial

This registry will make it possible to collect large-scale data on SAPL patients, particularly those treated with DOACs, in order to better assess the frequency of thrombotic and hemorrhagic events in this population of "non-high-risk" thrombotic SAPL patients treated with DOACs. The results will help refine treatment recommendations and could form the basis of future clinical trials.

In this study, there will be no modification of the usual care and no additional follow-up. Follow-up will be carried out during the patient's usual visits in the context of his or her pathology, the frequency of which will be left to the discretion of the usual physician. No additional consultations/hospitalizations/examinations will be carried out as part of the study. Data normally recorded in the medical record will be collected over a 5-year period, in line with standard patient follow-up.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Person having received complete information on the organization of the research and not having opposed the use of this data

Male or female aged 18 and over;

Carrier of a thrombotic APS according to the Sydney classification criteria, regardless of the length of time in the disease

Having received a direct oral anticoagulant (DOAC) treatment which is currently discontinued.

Disqualifiers

Incomplete Sydney classification criteria

Presence of a triple antiphospholipid positivity

History of arterial thrombosis

Pregnant, parturient or nursing mother

Trial population

Population of "non-high-risk" thrombotic SAPL patients treated with DOACs. Given current recommendations, SAPL patients at "high risk" of thrombosis (triple positivity, history of arterial thrombosis) should not be treated with DOACs and will not be included. Recruitment will be carried out via the departments authorized to manage these patients, at the time of their consultation or hospitalization. Patients will be invited to participate in the study as part of their regular follow-up visit. Services: services authorized to care for these patients within the open international investigator hospitals

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • "non-high risk" thrombotic APS patients treated with DOAC

    Other intervention

    There is no specific intervention in this study. Routine care data will be collected from patients with a 'non-high-risk' APS profile who are currently being treated with DOACs or have been in the past.

Treatment groups

500 Participants
are divided into 1 treatment group
Group A: Population of "non-high risk" thrombotic APS patients treated with DOAC1 intervention

Trial outcomes

Primary outcomes

1

Frequency of thrombotic complications

Occurrence of thrombotic recurrence within 5 years of inclusion confirmed by a reference examination : * PE: CT angiography, ventilation / perfusion scintigraphy * Stroke: MRI or brain scan * Venous or peripheral arterial thrombosis: Doppler ultrasound, CT angiography, MRI * MI or cardiac microcirculatory impairment: ECG and troponin, coronary angiography, TTE, MRI * Skin: skin biopsy * Adrenal or intra-alveolar hemorrhage: CT scan or MRI

Time frame
From enrollment to the thrombotic recurrence or the end of the study (5 years post-inclusion)

Secondary outcomes

1

Risk Factors of thrombotic recurrence

Occurrence of a venous, arterial or microcirculatory thrombotic recurrence confirmed by a baseline examination (detailed in the primary endpoint)

Time frame
From enrollment to the thrombotic recurrence or the end of the study (5 years post-inclusion)
2

Frequency of manifestations associated with APS (non-criteria manifestations according to the Sydney classification criteria)

Occurrence of non-criteria manifestations according to the Sydney criteria: thrombocytopenia, hemolytic anemia, valve disease, livedo, nephropathy due to APS, superficial venous thrombosis, chorea

Time frame
From enrollment to the thrombotic recurrence or the end of the study (5 years post-inclusion)
3

Frequency of hemorrhages and other adverse events

Occurrence of hemorrhagic accident according to the definition of the International Society on Thrombosis and Haemostasis

Time frame
From enrollment to the thrombotic recurrence or the end of the study (5 years post-inclusion)

Other outcomes

Sponsors and contacts

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

This trial is not recruiting at the moment. You can still explore other options: