OBServaToIre interNational Des Patients AnTiphospholipidEs traités Par Anticoagulants Oraux Directs

NCT06929182 | Not Yet Recruiting

• 1 other identifier: 2025PI048
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Antiphospholipid Syndrome (APS); Direct Oral Anticoagulants (DOACs); Thrombotic and Bleeding Events; Safety

Keywords

safety of DOACs; "non-high risk" APS patients; Observatory; Phase IV; International

Outcome Measures

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

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

Secondary Outcomes (3)

• Risk Factors of thrombotic recurrence

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

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

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

• Frequency of hemorrhages and other adverse events

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

Study Arms (1)

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

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

Interventions

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

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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

You may qualify if:

• 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

You may not qualify if:

• Incomplete Sydney classification criteria
• Presence of a triple antiphospholipid positivity
• History of arterial thrombosis
• 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
• 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.
• Signature of the research participation opposition form

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

Vall d´Hebron University Hospital

Barcelona, 08035, Spain

Location

Related Publications (3)

• Pengo V, Denas G, Zoppellaro G, Jose SP, Hoxha A, Ruffatti A, Andreoli L, Tincani A, Cenci C, Prisco D, Fierro T, Gresele P, Cafolla A, De Micheli V, Ghirarduzzi A, Tosetto A, Falanga A, Martinelli I, Testa S, Barcellona D, Gerosa M, Banzato A. Rivaroxaban vs warfarin in high-risk patients with antiphospholipid syndrome. Blood. 2018 Sep 27;132(13):1365-1371. doi: 10.1182/blood-2018-04-848333. Epub 2018 Jul 12.

  PMID: 30002145 BACKGROUND

• Dufrost V, Risse J, Reshetnyak T, Satybaldyeva M, Du Y, Yan XX, Salta S, Gerotziafas G, Jing ZC, Elalamy I, Wahl D, Zuily S. Increased risk of thrombosis in antiphospholipid syndrome patients treated with direct oral anticoagulants. Results from an international patient-level data meta-analysis. Autoimmun Rev. 2018 Oct;17(10):1011-1021. doi: 10.1016/j.autrev.2018.04.009. Epub 2018 Aug 11.

  PMID: 30103045 BACKGROUND

• Cohen H, Hunt BJ, Efthymiou M, Arachchillage DR, Mackie IJ, Clawson S, Sylvestre Y, Machin SJ, Bertolaccini ML, Ruiz-Castellano M, Muirhead N, Dore CJ, Khamashta M, Isenberg DA; RAPS trial investigators. Rivaroxaban versus warfarin to treat patients with thrombotic antiphospholipid syndrome, with or without systemic lupus erythematosus (RAPS): a randomised, controlled, open-label, phase 2/3, non-inferiority trial. Lancet Haematol. 2016 Sep;3(9):e426-36. doi: 10.1016/S2352-3026(16)30079-5.

  PMID: 27570089 BACKGROUND

MeSH Terms

Conditions

Antiphospholipid Syndrome

Interventions

N(4)-oleylcytosine arabinoside

Condition Hierarchy (Ancestors)

Autoimmune Diseases; Immune System Diseases

Study Officials

• Virginie DUFROST, MD

  CHRU - Nancy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 8, 2025
• First Posted: April 16, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 1, 2035
• Study Completion (Estimated): July 1, 2035
• Last Updated: April 20, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)