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Clotting and bleeding in antiphospholipid syndrome patients taking direct oral anticoagulants

Follows people with antiphospholipid syndrome taking direct oral anticoagulants.

Key facts

Who runs it
Central Hospital, Nancy, France
Where
Spain1 site in 1 countryChoose a country to see its sites
Trial code
Registry title
OBServaToIre interNational Des Patients AnTiphospholipidEs traités Par Anticoagulants Oraux Directs
Status
Not yet recruiting
People taking part
500 people, planned
Started
1 Jul 2025
Expected to end
1 Jul 2035
Type of study
Observational
Treatments tested
  • "non-high risk" thrombotic APS patients treated with DOAC
Record updated
20 April 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with thrombotic antiphospholipid syndrome (APS) who take, or have taken, a direct oral anticoagulant (DOAC). It is a registry that collects data from usual care over 5 years.

Age
18 and over
Sex
All
Disease stage
Thrombotic APS according to the Sydney classification criteria, for any length of time. Only "non-high-risk" APS: no past artery clots.
Earlier treatment
People must be on DOAC treatment now, or have had DOAC treatment that is now stopped.
Biomarker or test result
No triple antiphospholipid positivity (all three antiphospholipid tests positive).

Main reasons for not taking part

  • Sydney classification criteria not fully met
  • All three antiphospholipid tests positive
  • Past blood clot in an artery
  • Pregnant women, women giving birth or breastfeeding
  • Adults under legal protection or unable to give consent

The registry criteria, word for word

Show all 11 criteriaShow less

Who can take part

  • 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
  • Or currently treated with DOAC

Who cannot take part

  • History of arterial thrombosis
  • Persons deprived of their liberty by a judicial or administrative decision, persons undergoing psychiatric treatment under Articles L. 3212-1 and L. 3213-1 of the French Public Health Code
  • Persons referred to in Articles L. 1121-5, L. 1121-7 and L1121-8 of the French Public Health Code:; Pregnant, parturient or nursing mother; Minor person (not emancipated); Adult person subject to a legal protection measure (guardianship, curatorship, safeguard of justice); Person of full age unable to express consent
  • Incomplete Sydney classification criteria
  • Presence of a triple antiphospholipid positivity
  • Signature of the research participation opposition form

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The group in the trial

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

    Non-high-risk" APS is defined by the absence of a history of arterial or microcirculatory thrombosis, the absence of valvulopathy related to APS, and a biological profile with only one or two positive antiphospholipid tests

    Treatment: "non-high risk" thrombotic APS patients treated with DOAC

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
OBServaToIre National Des Patients AnTiphospholipidEs traités Par Anticoagulants Oraux Directs
Plain-language title
Clotting and bleeding in antiphospholipid syndrome patients taking direct oral anticoagulantsGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 15 November 2026.
Record updated
20 April 2025