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Study identifier: NCT03890601 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

New Biological Tests in Patients With Antiphospholipid Antibodies

Condition: Antiphospholipid Syndrome  ·  Sponsor: Hospices Civils de Lyon

PhaseN/A
Planned participants150
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

Antiphospholipid syndrome (APS) is an autoimmune disease characterized by thromboembolic events or pregnancy complications associated with circulating antiphospholipid antibodies (aPL-Abs). APS diagnosis needs the presence of both clinical and serological criteria (SAPORRO criteria, updated with Sydney criteria in 2006). However, no correlation between laboratory assays and the clinical thrombosis risk in patients with aPL-Abs was observed as only few patients with aPL-Abs developed clinical manifestations. Thrombin generation assays (TGA) is a global coagulation test that may represent a certain interest to evaluate thrombosis risk as a high thrombin generation capacity seems to be an independent risk factor for recurrent thromboembolic events. Another point of interest to assess the thrombotic risk is the detection of autoantibodies recognizing domain 1 of β2Gp1 (aβ2GP1-dm1). These autoantibodies are strongly related correlated with thrombotic and pregnancy manifestations. Recently, a commercial chemiluminescence immunoassay (CLIA) for detection of aβ2GP1-dm1 became available on Acustar® analyzer (HemosIL Acustar®, Instrument Laboratory, Bedford, USA) to facilitate aβ2GP1-dm1 research. The aim of this study is to evaluate two additional laboratory assays to improve the correlation between laboratory assays and the clinical thrombosis risk in patients with antiphospholipid (APL): thrombin generation assay and aβ2GP1-dm1. Each biological result (Antibodies to Domain 1 (Dm1) …

This description comes directly from the study's public registry record.

Talk to the study team

Yesim DARGAUD, PH  ·  4.72.11.88.10  ·  gamze.dargaud@chu-lyon.fr

Stéphanie Désage  ·  stephanie.desage@chu-lyon.fr

Always discuss trial participation with your own doctor first.

Locations (4)

Hôpital Cardiologique Louis PradelBron, FranceRecruiting
CHU de Clermont-FerrandClermont-Ferrand, FranceNot Yet Recruiting
Hôpital Edouard HerriotLyon, FranceRecruiting
Centre Hospitalier Lyon SudPierre-Bénite, FranceRecruiting

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Source record: clinicaltrials.gov/study/NCT03890601